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BACKGROUND: The evolution and outcomes of extended pancreatectomies at a single institute over 15 years are presented in this study. METHODS: A retrospective analysis of the institutional database was performed from 2015 to 2022 (period B). Patients undergoing extended pancreatic resections, as defined by the International Study Group for Pancreatic Surgery, were included. Perioperative and survival outcomes were compared with data from 2007-2015 (period A). Regression analyses were used to identify factors affecting postoperative and long-term survival outcomes. RESULTS: A total of 197 (16.1%) patients underwent an extended resection in period B compared to 63 (9.2%) in period A. Higher proportions of borderline resectable (5 (18.5%) versus 51 (47.7%), P = 0.011) and locally advanced tumours (1 (3.7%) versus 24 (22.4%), P < 0.001) were resected in period B with more frequent use of neoadjuvant therapy (6 (22.2%) versus 79 (73.8%), P < 0.001). Perioperative mortality (4 (6.0%) versus 12 (6.1%), P = 0.81) and morbidity (23 (36.5%) versus 83 (42.1%), P = 0.57) rates were comparable. The overall survival for patients with pancreatic adenocarcinoma was similar in both periods (17.5 (95% c.i. 6.77 to 28.22) versus 18.3 (95% c.i. 7.91 to 28.68) months, P = 0.958). Resectable, node-positive tumours had a longer disease-free survival (DFS) in period B (5.81 (95% c.i. 1.73 to 9.89) versus 14.03 (95% c.i. 5.7 to 22.35) months, P = 0.018). CONCLUSION: Increasingly complex pancreatic resections were performed with consistent perioperative outcomes and improved DFS compared to the earlier period. A graduated approach to escalating surgical complexity, multimodality treatment, and judicious patient selection enables the resection of advanced pancreatic tumours.
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Pancreatectomia , Neoplasias Pancreáticas , Humanos , Masculino , Feminino , Estudos Retrospectivos , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/patologia , Neoplasias Pancreáticas/terapia , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Terapia Combinada , Terapia Neoadjuvante , Complicações Pós-Operatórias/epidemiologia , AdultoRESUMO
Importance: There is limited evidence with regard to the benefit of adjuvant chemotherapy chemoradiotherapy in resected gallbladder cancers (GBCs). Objective: To establish a baseline survival rate for operated GBCs in patients receiving either gemcitabine plus cisplatin (GC) or capecitabine and capecitabine concurrent with chemoradiation (CCRT). Design, Setting, and Participants: The GECCOR-GB study was a multicenter, open-label, randomized phase 2 noncomparator "pick the winner" design trial of adjuvant GC and CCRT in patients with resected histologically confirmed adenocarcinoma or adenosquamous carcinoma of the gallbladder, (stage II/III) with no local residual tumor (R0) or microscopic residual tumor (R1). The study was carried out in 3 tertiary cancer institutions in India. Patients 18 years or older with adequate end-organ functions, and Eastern Cooperative Oncology Group Performance Status of 1 or lower between May 2019 and February 2022 were enrolled. The cutoff date for data analysis was February 28, 2023. Interventions: Patients were randomized 1:1 to receive either GC every 3 weeks (maximum of 6 cycles) or CCRT comprising capecitabine with concurrent chemoradiation (capecitabine concurrent with radiotherapy) sandwiched between capecitabine chemotherapy. Main Outcomes and Measures: The primary outcome was disease-free survival (DFS) at 1 year in randomized patients. This study was conducted as 2 parallel, single-stage phase 2 clinical trials. Within each treatment arm, a 1-year DFS rate of less than 59% was considered as insufficient activity, whereas a 1-year DFS rate of 77% or higher would be considered as sufficient activity. Results: With a median follow-up of 23 months, 90 patients were randomized, 45 in each arm. Overall, there were 31 women (69%) and 14 men (31%) in the GC arm with a mean (range) age of 56 (33-72) years and 34 women (76%) and 11 men (24%) in the CCRT group with a mean (range) age of 55 (26-69) years. In the GC and CCRT arms, 1-year DFS and estimated 2-year DFS was 88.9% (95% CI, 79.5-98.3) and 74.8% (95% CI, 60.4-89.2), and 77.8% (95% CI, 65.4-90.2) and 74.8% (95% CI, 59.9-86.3), respectively. Completion rates for planned treatment was 82% in the GC arm and 62% in the CCRT arm. Conclusions and Relevance: In this randomized clinical trial, GC and CCRT crossed the prespecified trial end points of 1-year DFS in patients with resected stage II/III GBCs. The results set a baseline for a larger phase 3 trial evaluating both regimens in operated GBCs. Trial Registration: ClinicalTrials.gov Identifier: CTRI/2019/05/019323I.
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Protocolos de Quimioterapia Combinada Antineoplásica , Quimiorradioterapia , Cisplatino , Desoxicitidina , Neoplasias da Vesícula Biliar , Gencitabina , Humanos , Neoplasias da Vesícula Biliar/terapia , Neoplasias da Vesícula Biliar/mortalidade , Neoplasias da Vesícula Biliar/patologia , Neoplasias da Vesícula Biliar/tratamento farmacológico , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapêutico , Desoxicitidina/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , Cisplatino/uso terapêutico , Cisplatino/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Idoso , Quimioterapia Adjuvante , Adulto , Capecitabina/uso terapêutico , Capecitabina/administração & dosagem , Intervalo Livre de Doença , Carcinoma Adenoescamoso/terapia , Carcinoma Adenoescamoso/mortalidade , Carcinoma Adenoescamoso/patologiaRESUMO
BACKGROUND: CA 19-9 is an extremely useful biomarker for pancreatic ductal adenocarcinomas (PDACs). However, the optimal cut-off and prognostic significance at higher cut-offs are yet to be determined. METHODS: Retrospective analysis included patients with PDAC who underwent curative resection from January 2010 to May 2020 at Tata Memorial Centre, Mumbai. The pretherapy CA 19-9 was dichotomized using various cut-off levels and analysed. RESULTS: In 244 included patients, the median overall survival (OS) for those with CA19-9 level (IU/ml) < or >78, 200, 500, 1000, and 2000 was 27, 24, 23, 22, 21 months versus 18, 16, 15, 14, 13 months; respectively, and was statistically significant (p-value- 0.002, 0.001, 0.002, 0.002 and 0.004, respectively). The number of recurrences and mortality had significant correlation with CA 19-9 cut-offs. On multivariate analysis, adjuvant treatment completion (p-0.004) and decreasing or stable CA19-9 after Neoadjuvant therapy (NAT) (p- 0.031) were associated with improved OS. CONCLUSION: The prognostic significance of CA 19-9 was observed at all the cut-off levels examined, beyond mere elevated value as per the standard cut-off level. In patients with high CA19-9 level, surgery should be offered if technically and conditionally feasible, only when a response in CA19-9 level to NAT is achieved.
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Rahul Krishnatry The aim of this study was to translate and validate the European Organization for Research and Treatment for Cancer (EORTC) "Radiation Proctitis" (PRT-20) module in Hindi, Marathi, and Bangla languages. The EORTC PRT-20 was translated into Hindi, Marathi, and Bangla using EORTC guidelines. Two separate translators first translated the original questionnaire into the three regional languages, following which a reconciled forward translation was compiled. This reconciled version in each language was then back-translated into English by two other translators. This back-translated version was then compared with the original the EORTC questionnaire for correctness, and the preliminary questionnaires were formed in all three languages. The EORTC translation unit approved the questionnaires. The preliminary questionnaires were administered to 30 patients (10 for each language) diagnosed with rectal or anal canal cancer who had received pelvic radiotherapy and were at risk of developing PRT. None of the patients had seen the questionnaire before. After filling out the questionnaire, each patient was interviewed for difficulty in answering, confusion, understanding, or if any of the questions were upsetting and if patients would have asked the question differently. No changes were suggested for Marathi and Bangla translations. Two modifications were suggested in the Hindi translation, which was then retested in five patients and finalized. All the suggestions were incorporated into the preliminary questionnaires, which were sent back to the EORTC for final approval. After reviewing the entire report of pilot testing for the translated quality-of-life questionaire-PRT-20 in three languages, it was approved by the EORTC translation unit. The translated questionnaires were reliable, with Cronbach α values of 0.767, 0.799, and 0.898 for Hindi, Marathi, and Bangla, respectively. The Hindi, Marathi, and Bangla translations of PRT-20 have been approved by the EORTC and can be used in routine clinical practice.
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BACKGROUND OBJECTIVES: There is limited evidence studying the relationship of liver segmental dose and segmental volume changes. The segmental dose thresholds could potentially allow for segmental regeneration after liver stereotactic body radiation therapy (SBRT). Given improved survival in hepatocellular cancer (HCC) and liver metastases and more salvage therapy options, this has become an important clinical question to explore. This study assesses the impact of liver segmental dose on segmental volume changes (gain or loss) after SBRT. METHODS: Liver segmental contours were delineated on baseline and serial follow up triphasic computed tomography scans. The volumes of total liver and doses to total liver, uninvolved liver and individual segments were noted. A correlation was evaluated between liver/segmental volume and dose using Pearson's correlation. Furthermore, receiver operator's curve (ROC) analysis was performed to find the segmental dose, i.e . predictive for liver volume loss. RESULTS: A total of 140 non-tumour liver segments were available for analysis in 21 participants. Overall, 13 participants showed loss of overall liver volume and eight showed gain of overall liver volume. The median dose in segments reporting an increase in volume was 9.1 Gy (7-36 Gy). The median dose in segments losing volume was 15.5 Gy (1-49 Gy). On ROC analysis, segmental dose >11 Gy was associated with volume loss. On univariate analysis, only liver segmental dose contributed to a significant segmental volume loss. INTERPRETATION CONCLUSIONS: We propose from the findings of this study that in SBRT for large hepatocellular cancer or liver metastases, liver segments should be individually delineated. Furthermore, 3-5 liver segments may be preferentially subjected to <9 Gy to facilitate hepatocyte regeneration. Preferential sparing of uninvolved liver segments may improve outcomes in liver stereotaxyas lower segmental doses were associated with liver regeneration. This may have implications on future liver SBRT planning where segmental doses may be as important as the mean dose.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Radiocirurgia , Humanos , Neoplasias Hepáticas/radioterapia , Carcinoma Hepatocelular/radioterapia , Radiocirurgia/métodos , Resultado do Tratamento , Hepatócitos , Estudos RetrospectivosRESUMO
ABSTRACT: This review article examines the evidence-based management of colorectal cancers, focusing on topics characterized by ongoing debates and evolving evidence. To contribute to the scientific discourse, we intentionally exclude subjects with established guidelines, concentrating instead on areas where the current understanding is dynamic. Our analysis encompasses a thorough exploration of critical themes, including the evidence surrounding complete mesocolic excision and D3 lymphadenectomy in colon cancers. Additionally, we delve into the evolving landscape of perioperative chemotherapy in both colon and rectal cancers, considering its nuanced role in the context of contemporary treatment strategies. Advancements in surgical techniques are a pivotal aspect of our discussion, with an emphasis on the utilization of minimally invasive approaches such as laparoscopy and robotic surgery in both colon and rectal cancers, including advanced rectal cases. Moving beyond conventional radical procedures, we scrutinize the feasibility and implications of endoscopic resections for small tumors, explore the paradigm of organ preservation in locally advanced rectal cancers, and assess the utility of total neoadjuvant therapy in the current treatment landscape. Our final segment reviews pivotal trials that have significantly influenced the management of colorectal liver and peritoneal metastasis.
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Laparoscopia , Segunda Neoplasia Primária , Neoplasias Retais , Humanos , Neoplasias Retais/patologia , Reto/patologia , Laparoscopia/métodos , Terapia Neoadjuvante , Segunda Neoplasia Primária/cirurgiaRESUMO
BACKGROUND: There is limited data with regard to the use of modified 5-fluoroural-leucovorin-irinotecan-oxaliplatin (mFOLFIRINOX) in terms of tolerance and enabling total mesorectal excision (TME) of locally advanced rectal adenocarcinomas (LARC) with high-risk characteristics (T4b status, signet ring histology etc) post standard neoadjuvant long course chemoradiation (NACTRT) or short course radiation (SCRT) and chemotherapy. MATERIALS AND METHODS: Patients with LARC from January 2018 to December 2020 receiving mFOLFIRINOX post NACTRT/SCRT to facilitate TME were evaluated. The primary endpoint was assessment of grade 3 and grade 4 treatment related toxicity and TME rates. Event free survival (EFS), where event was defined as disease progression or recurrence post resection after mFOLFIRINOX, was calculated by Kaplan Meier method. RESULTS: Forty-seven patients were evaluated with a median age of 33 years (Range:18-59), 45% T4b status, 96% radiological circumferential margin (CRM) involved (79% CRM positive post NACTRT/SCRT), 43% extramural venous invasion (n=33) and 36% signet ring histology. 62% had received prior NACTRT and 38% had received SCRT with chemotherapy before receiving mFOLFIRINOX. The most common grade 3 and grade 4 treatment related side effects included diarrhoea (7%), anaemia (4%) and infections (4%). Intended duration of mFOLFIRINOX or beyond was completed in 94% of patients. 60% of patients underwent curative local resection with R0 resection rates of 100% (n=28) and pathological complete response rates of 21%. The most common surgeries done were exenterations and abdominoperineal in 22% and 17% patients respectively. With a median follow up of 19 months, 24 patients had recurred or progressed for a median EFS of 20 months [95% confidence interval (CI): 15-24]. CONCLUSIONS: Locally advanced rectal cancers with high-risk characteristics are a niche group of cancers with less-than-optimal outcomes post standard neoadjuvant strategies. mFOLFIRINOX appears to be well tolerated and enables TME in a significant proportion of these patients.
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Neoplasias Pancreáticas , Neoplasias Retais , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Terapia Neoadjuvante/efeitos adversos , Terapia Neoadjuvante/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Pancreáticas/patologia , Neoplasias Retais/tratamento farmacológico , Neoplasias Retais/patologia , Fluoruracila/efeitos adversos , Leucovorina/efeitos adversos , Quimiorradioterapia , Irinotecano , OxaliplatinaRESUMO
PURPOSE: To evaluate the outcomes of post-neoadjuvant chemoradiation (NACTRT) wait-and-watch Strategy (WWS) in distal rectal cancers. MATERIALS AND METHODS: All consecutive patients from December 2012 to 2019 diagnosed with distal rectal tumors (T2-T4 N0-N+) having a complete or near-complete response (cCR or nCR, respectively) post-NACTRT and wishing for the non-surgical treatment option of WWS were included in this study. Patients were observed with 3 monthly magnetic resonance imaging (MRIs), sigmoidoscopies, and digital rectal examination for 2 years and 6 monthly thereafter. Organ preservation rate (OPR), local regrowth rate (LRR), non-regrowth recurrence-free survival (NR-RFS) and overall survival (OAS) were estimated using the Kaplan-Meier method, and factors associated with LRR were identified on univariate and multivariate analysis using the log-rank test (P < 0.05 significant). RESULTS: Sixty-one consecutive patients post-NACTRT achieving cCR[44 (72%)] and nCR[17 (28%)], respectively, were identified. All patients received pelvic radiotherapy at a dose of 45-50Gy conventional fractionation and concurrent capecitabine. An additional boost dose with either an external beam or brachytherapy was given to 39 patients. At a median follow-up of 39 months, 11 (18%) patients had local regrowth, of which seven were salvaged with surgery and the rest are alive with the disease, as they refused surgery. The overall OPR, NR-RFS, and OS were 83%, 95%, and 98%, respectively. Seven (11%) patients developed distant metastasis, of which six underwent metastatectomy and are alive and well. LRR was higher in patients with nCR versus cCR (P = 0.05). CONCLUSION: The WWS is a safe non-operative alternative management for selected patients attaining cCR/nCR after NACTRT with excellent outcomes.
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Recidiva Local de Neoplasia , Neoplasias Retais , Humanos , Recidiva Local de Neoplasia/tratamento farmacológico , Conduta Expectante , Quimiorradioterapia/efeitos adversos , Quimiorradioterapia/métodos , Neoplasias Retais/patologia , Resultado do Tratamento , Exame Retal Digital , Terapia Neoadjuvante/efeitos adversosRESUMO
AIM: To translate and validate the European Organization for Research and Treatment for Cancer (EORTC) module for assessing the sexual health-related quality of life in cancer patients (QLQ-SH22), in Hindi, Marathi, and Bangla languages for clinical use. METHODS AND RESULTS: The EORTC QLQ-SH-22 was translated into Hindi, Marathi, and Bangla by adopting standard guidelines given by EORTC. Initially, the original questionnaire was forward translated by two separate translators, followed by the reconciliation of the forward translations by a third person. This was followed by two back translations of the reconciled version into English by two other translators. These back-translated questions were then compared with the original EORTC questions for accuracy, and once acceptable, a preliminary questionnaire was prepared in all three languages. These questionnaires were then pilot tested with 30 patients (10 for each language) diagnosed with any of the cancers in the pelvic region who are expected to be at risk of sexual quality of life due to tumor or treatment like pelvic radiotherapy. Participated patients had never seen or filled the questionnaire before, each patient was interviewed after filling the questionnaire for difficulty in answering, confusion, difficulty understanding, or if any of the questions were upsetting and if patients would have asked the question differently. RESULTS: None of the patients reported any changes or suggestions for all the three translations. All the translated questionnaires were well understood by all the patients. Pilot testing reports were sent to EORTC. After reviewing the entire report of Hindi, Marathi, and Bangla translations, these questionnaires were approved by the EORTC translation unit. The questionnaires are reliable with Cronbach's α for Hindi, Marathi, and Bangla being 0.69, 0.66, and 0.86, respectively. CONCLUSION: The final Hindi, Marathi, and Bangla translations of SH 22 have been approved by the EORTC and can be used to assess the sexual health of cancer patients in routine oncology practices and/or clinical studies.
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PURPOSE: To evaluate clinical outcomes of recurrent gynaecological cancers treated with reirradiation (reRT) using advanced brachytherapy (BT) technique. METHODS AND MATERIALS: Seventy-six women who underwent reRT with BT for gynaecological cancers at our institute between January 2000 and December 2019 were analysed to determine patient, disease and treatment characteristics and clinical outcomes. Descriptive analysis was used for demographics, and the Kaplan Meir method was used for survival analysis. RESULTS: Median age at recurrence was 55 years (Range: 35-73). Forty-three patients had recurrent cervical cancer with intact uterus, and 33 had recurrent vault/vaginal cancers post adjuvant RT. Eight patients received EBRT prior to BT (Range: 30-50Gy). Twenty-two patients (28.9%) received salvage chemotherapy before consideration of brachytherapy. Brachytherapy application was done using MUPIT in 38, Vienna applicator in 20, Syed Neblett in 8, central vaginal cylinder in 3, multicatheter intravaginal applicator in 2, tandem-ovoids in 4 and Houdek applicator in 1 patient. Median cumulative EQD2 for all courses of radiation was 108 Gy (IQR 92-123 Gy). At median follow up of 39 months, local control (LC), progression-free survival (PFS) and Overall survival (OS) at 2-years was 60%, 56.3%, and 72.9 respectively. Patients who had recurrences beyond 2 years had significantly better OS compared to early recurrences. Patients who received BT doses >40 Gy had a higher LC and PFS. Grade 3 to 4 late rectal toxicity was seen in 10 (13%), bladder toxicity in 6 (8%) and vaginal fibrosis in 24 (31%) patients. CONCLUSION: The use of advanced BT approach in reirradiation setting is a feasible and safe option in treatment of post-treatment recurrent cervical, endometrial, and vaginal cancers.
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Braquiterapia , Neoplasias dos Genitais Femininos , Reirradiação , Neoplasias Vaginais , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Neoplasias Vaginais/radioterapia , Braquiterapia/métodos , Dosagem Radioterapêutica , Recidiva Local de Neoplasia/radioterapia , Recidiva Local de Neoplasia/etiologiaRESUMO
PURPOSE: Evaluate MR patterns of response and their evolution in rectal cancer patients on watch and wait (WW). METHODS: We retrospectively reviewed 337 MRIs of 60 patients (median follow-up: 12 months; range: 6-49 months). Baseline MRIs (available in 34/60 patients) were evaluated for tumor morphology, location, thickness, circumferential involvement, nodal status and EMVI. First post-treatment MRIs (in all patients) were additionally evaluated for pattern of response on T2 and DWI. Change in post-treatment scar thickness and scar depth angle between the first and second post-treatment scans was also evaluated. Evolution of the response pattern/recurrence were evaluated till the last available scan. RESULTS: On the baseline scans, 20/34 (59%) patients had polypoidal tumor with 12/20 having ≤ 25% circumferential wall involvement. We saw five patterns of response-normalized rectal wall (2/60-3%), minimal fibrosis (23/60-38%), full thickness fibrosis (16/60-27%), irregular fibrosis (11/60-18%) and split scar (6/60-10%), with 2/60 (3%) showing possible residual disease. On the first post-treatment scans, 12/60 (20%) had restricted diffusion, with 3/12 having persistent restriction till last follow-up. Post-treatment fibrosis/split scar remained stable in 44/60 (73%) cases and improved further in the rest. 9/60 (15%) patients developed regrowth/recurrence. Patients with recurrence had < 10 mm scar thickness and < 21° change in scar angle between the first and second post-treatment MRIs. CONCLUSION: Most patients on WW protocol developed minimal or full thickness fibrosis, majority of which remained stable on follow-up.
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INTRODUCTION: Brachytherapy (BT) is integral in treatment of gynecological malignancies and is also an option for many other cancers. Data on training and proficiency levels of early career oncologists is limited. Like other continents a survey was conducted for early career oncologists in India. METHODS AND MATERIALS: An online survey was conducted from November 2019 to February 2020, through Association of Radiation Oncologists of India (AROI) for early career radiation oncologists expected to be within 6 years of training. The survey used a 22 item questionnaire that was also used for European survey. Responses to individual statements were recorded on a 1-5 Likert-type scale. Descriptive statistics were used to describe proportions. RESULTS: One-hundred twenty-four (17%) of 700 recipients responded to the survey. Majority of the respondents (88%) stated that being able to perform BT at the end of their training was important. Two-thirds of the respondents (81/124) had performed >10 intracavitary procedure and 22.5% had performed >10 intracavitary-interstitial implants. Many respondents had not performed nongynecological procedure- breast (64%), prostate(82%), gastro-intestinal (47%). Respondents predicted that in next 10 years, the role of BT is likely to increase. Lack of dedicated curriculum and training was perceived as the greatest barriers to achieving independence in BT (58%). Respondents suggested that BT training should be prioritized during conferences (73%) and online teaching modules (56%), along with development of BT skills labs (65%). CONCLUSION: This survey identified a lack of proficiency in gynecological intracavitary-interstitial brachytherapy and non-gynecological brachytherapy, despite BT training being regarded as highly important. Dedicated programs, including standardized curriculum and assessment need to be developed for training early- career radiation oncologists in BT.
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Braquiterapia , Neoplasias , Masculino , Humanos , Braquiterapia/métodos , Inquéritos e Questionários , Currículo , ÍndiaRESUMO
INTRODUCTION: Placement of biliary self-expanding metal stents (SEMS) has been effective for palliation of unresectable hilar malignant biliary obstruction. Optimal drainage in hilar obstruction may require placement of multiple stents. Data on multiple SEMS placement in hilar obstruction from India is sparse. METHODS: Retrospective review of patients with unresectable malignant hilar obstruction who underwent endoscopic bilateral SEMS insertion from 2017 to 2021 was done. Demographic details, technical success and functional success (decrease in the bilirubin value below 3 mg/dL at four weeks), immediate complications with 30-days mortality, requirement of re-intervention, stent patency and overall survival were studied. RESULTS: Forty-three patients were included (mean age 54.9 years, 51.2% females). Thirty-six patients (83.7%) had carcinoma gallbladder as primary malignancy. Twenty-six patients (60.5%) were metastatic at presentation. Cholangitis was seen in 4/43 (9.3%). On cholangiogram, 26 (60.4%) had Bismuth type II block, 12 (27.8%) had type IIIA/B, 5 (11.6%) had type IV block. Technical success was achieved in 41/43 (95.3%) patients (38, side-by-side SEMS placement; 3, SEMS-within-SEMS in Y fashion). Functional success was achieved in 39 patients (95.1%). No moderate-severe complications were reported. Median post-procedure hospitalization was five days. Median stent patency was 137 days (interquartile range [IQR] 80-214 days). Re-intervention was required in four patients (9.3%) after mean 295.7 days. Median overall survival was 153 days (IQR 108-234 days). CONCLUSION: Endoscopic bilateral SEMS in complex malignant hilar obstruction has good outcomes in the form of technical success, functional success and stent patency. Survival is dismal despite optimal biliary drainage.
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Neoplasias dos Ductos Biliares , Colangiocarcinoma , Colestase , Feminino , Humanos , Pessoa de Meia-Idade , Masculino , Atenção Terciária à Saúde , Stents/efeitos adversos , Colestase/cirurgia , Colestase/complicações , Metais , Estudos Retrospectivos , Ductos Biliares Intra-Hepáticos , Neoplasias dos Ductos Biliares/complicações , Resultado do TratamentoRESUMO
BACKGROUND: In rectal cancers, presence of extramural vascular invasion on MRI (mrEMVI) is associated with poor survival. The independent influence of mrEMVI in the presence of other prognostic factors has not been previously analyzed using match pair analysis. PATIENTS AND METHODS: Consecutive 92 patients having mrEMVI at presentation treated between January 2016 and December 2018 were matched with 92 patients (1:1) without mrEMVI. Matching parameters were T stage, mesorectal fascia involvement, and tumor differentiation. The presence and absence of mrEMVI were correlated to outcomes. An event was defined as locoregional failure or distant metastasis or poor response to chemoradiation rendering the rectal tumor as inoperable. RESULTS: At 3 years, in the mrEMVI-positive cohort, 59% had an event and in the mrEMVI-negative cohort, 45% had an event (p = 0.026). Local control was 90.2% (12recurrences in 122 who underwent surgery), two recurrences in the mrEMVI-positive cohort and ten patients in the mrEMVI-negative cohort, which missed statistical significance (p = 0.06). Distant metastasis-free survival was significantly worse in the mrEMVI-positive cohort versus the mrEMVI-negative cohort (58.2% vs. 69.4%) (p = 0.022). Similarly, Overall survival was significantly inferior in mrEMVI-positive cohort compared to the mrEMVI-negative cohort (57% vs. 72.4%) (p = 0.02). The multivariate regression analysis confirmed the independent predictive value of mrEMVI. CONCLUSION: Extramural vascular invasion detected through MRI is an independent risk factor for distant metastasis in the locally advanced carcinoma rectum. Aggressive treatment regimens like total neoadjuvant treatment should be considered in these cases pending randomized control studies.
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Segunda Neoplasia Primária , Neoplasias Retais , Humanos , Imageamento por Ressonância Magnética , Terapia Neoadjuvante , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Segunda Neoplasia Primária/patologia , Prognóstico , Pontuação de Propensão , Neoplasias Retais/patologia , Reto/diagnóstico por imagem , Reto/patologia , Estudos RetrospectivosRESUMO
PURPOSE: Pelvic irradiation leads to substantial dose to the pelvic girdle. However, bone density loss as a function of radiation therapy dose and time has not been investigated. This study was undertaken to evaluate such a dose-response relationship. METHODS AND MATERIALS: Women undergoing pelvic radiation therapy for cervix cancer within a phase 3 trial were included. The study necessitated 2 computed tomography imaging sets acquired at least 12 months apart in patients with no evidence of relapse. All images were transferred to the treatment planning system to determine radiation dose and Hounsfield unit (HU). Across the entire lumbopelvic region (lumbar 1-5 [L1-5] vertebrae, pubic symphysis, femur, acetabulum, greater trochanter, and anterior-superior iliac spine) multiple regions were defined to measure radiation therapy dose and HU. Bone health was categorized as normal if >130 HU, osteopenic at 110 to 130 HU, and osteoporotic <110 HU at baseline and follow-up. Univariate analysis was performed to test the effect of various factors on HU. Further interaction among radiation therapy dose, time, and HU was assessed using a linear mixed model. RESULTS: Overall, 132 of 300 patients were eligible. The median age was 49 (42-56) years. With a prescription dose of 50 Gy, the L1 and L2 vertebrae received a median dose of 1.2 and 4 Gy, respectively, and L3-5 received 10 to 50 Gy. At 24 months, median HU loss at L4-5 was 45 HU (interquartile range, 34-77 HU). Out of the 132 patients, at baseline 96% had normal bone health. However, at the last follow-up, 3% of patients had normal bone health, 12% developed osteopenia, and 85% developed osteoporosis (P < .001). There were no patient- or treatment-related factors predicted for HU loss on univariate analysis. HU loss >60 to 70 was observed at >45 Gy at L5 vertebra (60-70 HU, P < .02) and >15 Gy at L4 vertebra (33 HU; P = .04). CONCLUSIONS: Dose-response relationship is observed between radiation dose and bone mineral density loss. Prospective studies are needed to corroborate these observations and design future interventions.
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Densidade Óssea , Osteoporose , Absorciometria de Fóton/métodos , Densidade Óssea/efeitos da radiação , Feminino , Humanos , Vértebras Lombares/diagnóstico por imagem , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Estudos RetrospectivosRESUMO
PURPOSE: Delivery of cancer care during the pandemic required adopting various changes in the standard management. We analyzed the impact of the first wave of the COVID-19 pandemic on radiation oncology treatment practices at Tata Memorial Hospital in India. MATERIALS AND METHODS: From March 1 to October 31, 2020, all consecutive patients who attended the radiation oncology department for radiotherapy treatment were included in this study. Electronic medical records, patient files, and telephonic consult were used to collect patient's data including changes in the standard treatment practice, COVID-19 testing and its results, and subsequent impact on radiotherapy treatment. Comparison was done with the same period data of 2019 for the number of the caseload, radiotherapy regimen, referral rates, and noncompliance rates. RESULTS: Our study included 4,256 patients with a median age of 52 years (interquartile range 41-61 years). There was a significant drop in the new-patient registrations (approximately 63%), radiotherapy consultations (44.9%), and referrals to other centers (27.8%). The reduction in the caseload was highest for genitourinary cases (-58.5%) and the lowest for breast cases (-11.5%) when compared with the 2019 cohort. Among those treated with radical intent, the noncompliance rate was 15%. Hypofractionation was the commonly adopted regimen across all sites. Compared with 2019, the maximum reduction in the average fractions per patient was seen in the breast cancer cases (-8.2 fraction), followed by genitourinary cases (-4.9 fraction). Of the 27.8% of patients tested for COVID-19, 13.4% turned positive and 3.4% died due to the disease. CONCLUSION: The COVID-19 pandemic adversely affected the number of radiotherapy consultations and treatments at our institute. However, our department offered uninterrupted services despite grave challenges. Hypofractionated regimen was used across disease sites to minimize patient visits and allow planned treatment completion. Radiotherapy was delivered safely, and patients experienced low rates of COVID positivity during radiotherapy and even lower mortality.
Assuntos
COVID-19 , Radioterapia (Especialidade) , Adulto , COVID-19/epidemiologia , Teste para COVID-19 , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , PandemiasRESUMO
Magnetic resonance imaging (MRI) has a key role to play at multiple steps of the radiotherapy (RT) treatment planning and delivery process. Development of high-precision RT techniques such as intensity-modulated RT, stereotactic ablative RT, and particle beam therapy has enabled oncologists to escalate RT dose to the target while restricting doses to organs at risk (OAR). MRI plays a critical role in target volume delineation in various disease sites, thus ensuring that these high-precision techniques can be safely implemented. Accurate identification of gross disease has also enabled selective dose escalation as a means to widen the therapeutic index. Morphological and functional MRI sequences have also facilitated an understanding of temporal changes in target volumes and OAR during a course of RT, allowing for midtreatment volumetric and biological adaptation. The latest advancement in linear accelerator technology has led to the incorporation of an MRI scanner in the treatment unit. MRI-guided RT provides the opportunity for MRI-only workflow along with online adaptation for either target or OAR or both. MRI plays a key role in post-treatment response evaluation and is an important tool for guiding decision making. In this review, we briefly discuss the RT-related applications of MRI in the management of brain, prostate, and GI malignancies.
Assuntos
Neoplasias Encefálicas , Neoplasias Gastrointestinais , Imageamento por Ressonância Magnética , Neoplasias da Próstata , Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/radioterapia , Neoplasias Gastrointestinais/diagnóstico por imagem , Neoplasias Gastrointestinais/radioterapia , Humanos , Masculino , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Radioterapia (Especialidade) , Dosagem RadioterapêuticaRESUMO
Background: Adverse event reporting in oncology trials lacks temporal description. We propose a toxicity summarizing method that incorporates time. Methods: Patients recruited in a phase III trial (NCT01279135) that compared three-dimensional conformal radiotherapy (3DCRT) and intensity modulated radiotherapy (IMRT) for late toxicity in cervical cancer were included. Adverse events were reported using Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and quality of life (QOL) with EORTC QLQ-C30 and CX24. A total of six symptoms with a related QOL question (diarrhoea, abdominal pain, anorexia, urinary incontinence, frequency and fatigue) were included. Month and severity score [MOSES= ∑ (CTCAE grade x proportionate time)] was calculated. Cumulative-MOSES (C-MOSES) was calculated by summating these 6 individual MOSES. QoL was categorized as "substantially symptomatic" or "not". Receiver operator curve analysis was performed to determine the MOSES cut off that predicts for substantial QOL symptoms. CTCAE and MOSES were tested for accurately categorizing QOL impact. Findings: In the construction dataset, 201/300 patients had symptoms. MOSES > 0.20 had higher accuracy than CTCAE for predicting impact on QOL related to diarrhoea (85% vs. 69%), anorexia (61% vs 51%), abdominal pain (71% vs. 57%), urinary incontinence (72% vs. 61%) and frequency (62% vs. 59%). C-MOSES > 0·70 correlated with reduction in role functioning and global QOL. While no difference was seen in CTCAE grade ≥1 Gastrointestinal (GI) toxicity between 3DCRT or IMRT arm, 3DCRT had higher C-MOSES than IMRT (HR=0.64;95% CI 0.41-0.99, p = 0.04). Interpretation: MOSES has higher accuracy than CTCAE in categorizing symptom specific and functional QOL. These results require further external validation. Funding: None.
RESUMO
INTRODUCTION: In locally advanced cervical cancer, nodal, local and distant relapse continue to be significant patterns of relapse. Therefore, strategies to improve the efficacy of chemoradiation are desirable such as biological pathway modifiers and immunomodulating agents. This trial will investigate the impact of nelfinavir, a protease inhibitor that targets the protein kinase B (AKT) pathway on disease-free survival (DFS). METHODS AND ANALYSIS: Radiosensitising effect of nelfinavir in locally advanced carcinoma of cervix is a single-centre, open-label, parallel-group, 1:1 randomised phase-III study. Patients aged over 18 years with a diagnosis of carcinoma cervix stage III are eligible for the study. After consenting, patients will undergo randomisation to chemoradiation and brachytherapy arm or nelfinavir with chemoradiation and brachytherapy arm. The primary aim of the study is to compare the difference in 3-year DFS between the two arms. Secondary aims are locoregional control, overall survival, toxicity and quality of life between the two arms. Pharmacokinetics of nelfinavir and its impact on tumour AKT, programmed cell death ligand 1, cluster of differentiation 4, cluster of differentiation 8 and natural killer 1.1 expression will be investigated. The overall sample size of 348 with 1 planned interim analysis achieves 80% power at a 0.05 significance level to detect a HR of 0.66 when the proportion surviving in the control arm is 0.65. The planned study duration is 8 years. ETHICS AND DISSEMINATION: The trial is approved by the Institutional Ethics Committee-I of Tata Memorial Hospital, Mumbai (reference number: IEC/0317/1543/001) and will be monitored by the data safety monitoring committee. The study results will be disseminated via peer-reviewed scientific journals, and conference presentations. Study participants will be accrued after obtaining written informed consent from them. The confidentiality and privacy of study participants will be maintained. TRIAL REGISTRATION NUMBER: The trial is registered with Clinical Trials Registry-India (CTRI/2017/08/009265) and ClinicalTrials.gov (NCT03256916).
Assuntos
Braquiterapia , Neoplasias do Colo do Útero , Adulto , Ensaios Clínicos Fase III como Assunto , Feminino , Humanos , Pessoa de Meia-Idade , Nelfinavir/uso terapêutico , Recidiva Local de Neoplasia , Proteínas Proto-Oncogênicas c-akt , Qualidade de Vida , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/terapiaRESUMO
Background: For nonmetastatic locally advanced gallbladder cancer (LAGBC) which remains unresectable and nonmetastatic after chemotherapy, there is no consensus on whether to continue chemotherapy or add local radiotherapy (RT) for improving outcomes. Materials and Methods: Forty-five patients of surgically unresectable nonmetastatic LAGBC were analyzed. Twenty patients did not receive RT (no RT cohort) and received only chemotherapy, while 25 patients received RT (RT cohort) with conformal techniques along with concurrent gemcitabine-based chemotherapy. No RT and RT cohorts were compared for disease-related outcomes and toxicities. Results: Median follow-up of the entire cohort was 11.5 months. Two-year progression-free survival (18.6% vs. 0%, P = 0.0001) and overall survival (37.3% vs. 5%, P = 0.0001) were significantly better in the RT cohort as compared to a no RT cohort. More number of patients had locoregional progression in the no RT cohort (85% vs. 32%, P = 0.0002). Radiation-induced acute and late gastrointestinal toxicity ≥ RTOG Grade 3 were seen in one and two patients, respectively. Conclusion: Addition of local RT to chemotherapy improves the survival outcomes and can be considered as a definite treatment modality for nonmetastatic LAGBC patients not amenable to surgery who have responded to chemotherapy.