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1.
Artigo em Inglês | MEDLINE | ID: mdl-34757580

RESUMO

PURPOSE: The data on the prognostic significance of red cell distribution width (RDW) in gallbladder cancers is sparse, especially in the potentially resectable cohort of patients. The aim was to assess the prognostic significance of RDW in gallbladder cancer patients undergoing surgery. METHODS: Retrospective analysis of prospectively maintained database of gallbladder cancer patients undergoing surgery at a tertiary cancer institute from 2010 till 2018. Baseline values were collected. Patients were grouped as per the median RDW value and compared. Survival analysis was done using the Kaplan Meier method. RESULTS: A total of 605 patients were included. The median follow up period was 23 months (range: 6-120 months). The median value of RDW was 14. Comparison between RDW > 14 and RDW < 14 groups showed no difference in outcomes. RDW did not predict overall survival or recurrences. However, in combined stages II and III, a statistically significant improvement in OS and DFS (p < 0.001) was noted in the RDW < 14 group. CONCLUSION: RDW did not predict recurrence or survival in potentially resectable gallbladder cancer patients. However, in the subset of stages II and III in combination, lower RDW value was associated with better outcomes. More prospective studies are needed to conclusively establish the prognostic value of RDW.

2.
Am J Surg ; 2021 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-34756584

RESUMO

AIM: This study aimed to assess the impact of treatment sequencing on long-term survival, in distal gastric cancers (GCs) (stage IB/II/III). METHODS: This retrospective study included patients with distal GC undergoing D2 resection. Outcomes were compared between group 1 (surgery with adjuvant chemotherapy) and group 2 (perioperative chemotherapy with surgery). 1:1 matching for baseline characteristics (age, cT, and cN stage) was performed for outcome comparison. RESULTS: At a median follow-up of 47.5 months in the included 342 patients, the 5-year overall survival (OS) was 61.1% and disease-free survival (DFS) was 50.5%. OS was comparable in the unmatched (group 1, n = 118; group 2, n = 224) (HR 0.905, 95%CI 0.64-1.33, P = 0.615) and matched groups (group 1, n = 97; group 2, n = 97) (HR 0.77, 95% CI 0.48-1.26, P = 0.3). CONCLUSION: D2 resection followed by adjuvant chemotherapy provides similar long-term outcomes as compared to perioperative chemotherapy approach for stage IB/II/III distal GCs.

3.
Front Oncol ; 11: 710585, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34568037

RESUMO

Background: Treatment of malignant melanoma has undergone a paradigm shift with the advent of immune checkpoint inhibitors (ICI) and targeted therapies. However, access to ICI is limited in low-middle income countries (LMICs). Patients and Methods: Histologically confirmed malignant melanoma cases registered from 2013 to 2019 were analysed for pattern of care, safety, and efficacy of systemic therapies (ST). Results: There were 659 patients with a median age of 53 (range 44-63) years; 58.9% were males; 55.2% were mucosal melanomas. Most common primary sites were extremities (36.6%) and anorectum (31.4%). Nearly 10.8% of the metastatic cohort were BRAF mutated. Among 368 non-metastatic patients (172 prior treated, 185 de novo, and 11 unresectable), with a median follow-up of 26 months (0-83 months), median EFS and OS were 29.5 (95% CI: 22-40) and 33.3 (95% CI: 29.5-41.2) months, respectively. In the metastatic cohort, with a median follow up of 24 (0-85) months, the median EFS for BSC was 3.1 (95% CI 1.9-4.8) months versus 3.98 (95% CI 3.2-4.7) months with any ST (HR: 0.69, 95% CI: 0.52-0.92; P = 0.011). The median OS was 3.9 (95% CI 3.3-6.4) months for BSC alone versus 12.0 (95% CI 10.5-15.1) months in any ST (HR: 0.38, 95% CI: 0.28-0.50; P < 0.001). The disease control rate was 51.55%. Commonest grade 3-4 toxicity was anemia with chemotherapy (9.5%) and ICI (8.8%). In multivariate analysis, any ST received had a better prognostic impact in the metastatic cohort. Conclusions: Large real-world data reflects the treatment patterns adopted in LMIC for melanomas and poor access to expensive, standard of care therapies. Other systemic therapies provide meaningful clinical benefit and are worth exploring especially when the standard therapies are challenging to administer.

5.
Ann Surg Oncol ; 2021 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-34283313

RESUMO

BACKGROUND: pN3 or ypN3 stage gastric cancers (GCs) are known to have aggressive clinical behaviour. This study aimed to investigate factors affecting survival and pattern of recurrences of N3 stage GCs, treated with curative intent. METHODS: A total of 196 GC patients, operated on at the Tata Memorial Centre from 2003 to 2017 and reported as pN3 or ypN3 status on histopathology after D2 gastrectomy were included in this retrospective analysis. RESULTS: On multivariate analysis, use of NACT (neoadjuvant chemotherapy) and LN ratio (≤ 0.5/> 0.5) emerged as significant predictors for long-term survival. Patients who received NACT but were still harbouring N3 nodes (ypN3; n = 102) had a worse prognosis than those operated on upfront (pN3; n = 94), with a median survival of 19 months versus 24 months respectively (p = 0.003). The 5-year overall survival of the entire cohort was 16.3% (95% CI 12.8-19.8%), while 5-year disease-free survival (DFS) was 14.6% (95% CI 12.6-20%). Adjuvant chemoradiotherapy, though offered in a small number of patients (n = 38) resulted in improvement in DFS. Median DFS of adjuvant CT versus adjuvant CRT was 13 months versus 23 months (p = 0.020). The commonest site of relapse was the peritoneum (49.18%) and incidence of isolated loco-regional failure was 10.7%. CONCLUSION: In GCs with N3 stage determined after radical D2 gastrectomy, LN ratio of > 0.5 and ypN3 status are predictors of poor prognosis. Considering the high incidence of peritoneal and loco-regional relapse in these patients, the role of more radical surgery, adjuvant chemoradiotherapy after upfront resection and intraperitoneal chemotherapy should be evaluated in prospective randomized clinical trials.

6.
J Surg Oncol ; 124(4): 572-580, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34106475

RESUMO

BACKGROUND: Presence of jaundice in gallbladder carcinoma (GBC) is considered a sign of inoperability with no defined treatment pathways. METHODS: Retrospective analysis of all surgically treated GBC patients from January 2010 to December 2019 was performed for evaluating etiology of obstructive jaundice, resectability, postoperative morbidity, mortality, disease-free survival (DFS) and overall survival (OS). RESULTS: Out of 954 patients, 521 patients (54.61%) were locally advanced gallbladder carcinoma (LAGBC: Stage III and IV) and 113 patients (11.84%) had jaundice at presentation. Thirty-four (30%) patients had benign cause of obstructive jaundice. Median OS of the whole cohort (n=113) was 22 months (16.5-27.49 months) with resectability rate of 62% (70/113). Median OS of curative resection group (n=70) was 32 months and DFS was 25 months. Treatment completion was achieved in 30% (n= 21/70) patients with median OS of 46 months and median DFS of 27 months. Isolated bile duct infiltration subgroup fared the best with median OS of 74 months with a 5-year survival of 66.7%. CONCLUSION: Surgical resection as a part of multimodality treatment improves survival in carefully selected locally advanced gallbladder cancer patients with jaundice. Early introduction of systemic therapy is the key in the management of this disease with aggressive tumor biology.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Colecistectomia/normas , Neoplasias da Vesícula Biliar/terapia , Icterícia Obstrutiva/complicações , Adulto , Terapia Combinada , Gerenciamento Clínico , Feminino , Seguimentos , Neoplasias da Vesícula Biliar/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Taxa de Sobrevida
7.
BMJ Open ; 11(6): e047376, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34187825

RESUMO

IMPORTANCE: The Cancer Aging Research Group (CARG) toxicity score is used to assess toxicity risk in geriatric patients receiving chemotherapy. OBJECTIVE: The primary aim was to validate the CARG score in geriatric patients treated with curative intent chemotherapy in predicting grade 3-5 toxicities. DESIGN: This was a longitudinal prospective observational study. SETTING: Tata Memorial Hospital, Mumbai, India, a tertiary cancer care referral centre. PARTICIPANTS: Patients, aged ≥65 years, with gastrointestinal, breast or gynaecological stage I-III cancers being planned for curative intent chemotherapy. A total of 270 patients were required for accrual in the study. EXPOSURES: Total risk score ranged from 0 (lowest toxicity risk) to 19 (highest toxicity risk). MAIN OUTCOMES AND MEASURES: The primary endpoint of the study was to evaluate whether the CARG risk score predicted for grade 3-5 toxicities. RESULTS: The study cohort of 270 patients had a mean age of 69 (65-83) years, with the most common cancers being gastrointestinal (79%). Fifty-two per cent of patients had atleast one grade 3-5 toxicity. The risk of toxicity was increased with an increasing risk score (42% low risk, 51% medium risk and 79% high risk; p<0.001). There was no association between either Eastern Cooperative Oncology Group (ECOG) performance status (p=0.69) or age-adjusted Charlson Comorbidity Index (p=0.79) risk categories and grade 3-5 chemotherapy toxicities. CONCLUSIONS AND RELEVANCE: This study validates the CARG risk score in predicting for grade 3-5 toxicities in geriatric oncology patients receiving curative intent chemotherapy and can be considered as the standard of care before planning chemotherapy in every elderly patient. TRIAL REGISTRATION NUMBER: CTRI/2016/10/007357; Results.


Assuntos
Antineoplásicos , Neoplasias , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica , Humanos , Índia , Neoplasias/tratamento farmacológico , Estudos Prospectivos , Medição de Risco
8.
Langenbecks Arch Surg ; 406(3): 821-831, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33733285

RESUMO

PURPOSE: The aim was to evaluate the oncological outcomes and the prognostic factors following pelvic exenteration (PE) in cT4 and fixed cT3 stage primary rectal adenocarcinoma and to study the impact of consolidation chemotherapy following neoadjuvant concurrent chemoradiotherapy (NACRT). METHODS: A retrospective analysis of a prospectively maintained database of PE from 2013 to 2018. RESULTS: Out of 2900 colorectal resections, there were 131 pelvic exenterations that were performed, and 100 of these patients had undergone exenteration for primary rectal adenocarcinoma. Of these 100 patients, there were 81 patients who had received NACRT followed by surgery, 50 of whom who had received consolidation chemotherapy and 31 who had undergone surgery without consolidation chemotherapy. R0 resection was achieved in 90% cases. At a median follow-up of 32 months, 2-year disease free survival was 61.8% and estimated 5-year overall survival was 62%. The incidence of distant metastases was 44% vs. 19% (p = 0.023), and the 2-year distant recurrence-free survival was 58% vs. 89% (p = 0.025), respectively, in the 'consolidation chemotherapy group' and the 'no chemotherapy group'. The poorly differentiated grade of tumours, presence of lympho-vascular-invasion, consolidation chemotherapy, and disease recurrence were all found to affect the survival. CONCLUSION: PE with R0 resection achieves excellent survival rates in cT4 and fixed cT3 stage primary rectal adenocarcinoma. The distant recurrence rate may not be altered by consolidation chemotherapy in the subset of high-risk patients. However, further research on consolidation chemotherapy following NACRT in cT4 and fixed cT3 stage primary rectal adenocarcinoma will give a definite answer in the future.


Assuntos
Adenocarcinoma , Neoplasias Retais , Adenocarcinoma/patologia , Adenocarcinoma/terapia , Quimiorradioterapia , Quimioterapia de Consolidação , Intervalo Livre de Doença , Humanos , Terapia Neoadjuvante , Recidiva Local de Neoplasia/terapia , Estadiamento de Neoplasias , Neoplasias Retais/patologia , Neoplasias Retais/terapia , Estudos Retrospectivos , Resultado do Tratamento
9.
Ann Surg Oncol ; 28(11): 6758-6766, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33625635

RESUMO

BACKGROUND: There is a lack of consensus on the ideal time interval and therapeutic value of revision surgery in patients with incidental gallbladder cancer (iGBC) in the context of multimodality management. PATIENTS AND METHODS: Retrospective analysis of an institutional database of patients with iGBC who underwent surgery from January 2010 to December 2019 was performed. Patients who underwent upfront surgery were divided into four time interval groups: A, B, C, and D (< 6 weeks, 6-10 weeks, 10-14 weeks, and > 14 weeks, respectively). RESULTS: A cohort of 517 patients planned for revision surgery was analyzed. Overall, 382 (73.9%) patients underwent upfront surgery while 135 (26.1%) were given neoadjuvant treatment. With median follow-up of 18 months, 2-year overall survival (OS) was 66% and disease-free survival (DFS) was 52.6%, with inferior survival outcomes observed with advancing stage and presence of residual disease on final histopathology. Propensity score-matched analysis after matching for pT stage of cholecystectomy specimen suggested a survival benefit for patients operated between 10 and 14 weeks in terms of OS (p = 0.049) and DFS (p = 0.006). Patients with locally advanced iGBC at presentation had superior OS when operated after neoadjuvant therapy [3-year estimated OS of 59.9% vs 32.3%, respectively (p = 0.001)]. CONCLUSIONS: Revision surgery is at best the most accurate staging procedure guiding timely initiation of systemic therapy. Patients with iGBC operated between 10 and 14 weeks after initial cholecystectomy tend to have favorable survival outcomes, although this depends on final disease stage. Revision surgery should also be offered to all patients presenting at any later point of time, if deemed operable.


Assuntos
Neoplasias da Vesícula Biliar , Colecistectomia , Neoplasias da Vesícula Biliar/patologia , Neoplasias da Vesícula Biliar/cirurgia , Humanos , Achados Incidentais , Estadiamento de Neoplasias , Reoperação , Estudos Retrospectivos
10.
J Nucl Med ; 62(11): 1558-1563, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33637590

RESUMO

We assessed 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in the neoadjuvant setting in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). We also evaluated the variables associated with resectability of the primary tumor after PRRT. Methods: This study included 57 GEP-NET patients who had a primary tumor that was unresectable (because of vascular involvement as defined using the pancreatic ductal adenocarcinoma criteria of the National Comprehensive Cancer Network) and who underwent 177Lu-DOTATATE therapy without any prior surgery. They were categorized into 2 groups: 23 patients without liver metastases (group 1) and 34 patients with potentially resectable liver metastases (group 2). 177Lu-DOTATATE was administered with mixed amino acid-based renal protection at a dose of 7.4 GBq (200 mCi) per cycle. Surgical resectability was evaluated using triphasic contrast-enhanced abdominal CT imaging at 3 different time points during the PRRT course. Four broad categories of overall PRRT response were evaluated. The Kaplan-Meier product-limit method was used to calculate progression-free survival (PFS) and overall survival (OS). Associations between variables and a resectable primary tumor after PRRT were analyzed using the χ2 test, with a P value of less than 0.05 considered statistically significant. Results: After 177Lu-DOTATATE therapy, the unresectable primary tumor became resectable in 15 of 57 (26.3%) patients (7 patients in group 1 and 8 patients in group 2). A complete or partial response to PRRT was seen in 48 patients (84%), 23 patients (40%), 18 patients (31%), and 23 patients (40%) using symptomatic, biochemical, molecular imaging, and anatomic imaging criteria, respectively. Estimated rates of PFS were 95% and 90% at 2 y in groups 1 and 2, respectively. The 2-y OS of the 2 groups combined was 92.1%. The rate at which the primary tumor was resectable after PRRT was significantly higher in patients who had duodenal neuroendocrine tumors, patients who had GEP-NETs with no regional lymph node involvement, patients for whom the primary tumor was smaller than 5 cm, patients for whom liver metastases were no larger than 1.5 cm, patients for whom there were no more than 3 liver metastases, and patients for whom 18F-FDG uptake in the primary tumor had an SUVmax of less than 5. Conclusion: In a moderate fraction of GEP-NET patients, with or without liver metastases, whose primary tumor was unresectable because of vascular involvement, the primary tumor converted from unresectable to resectable after 177Lu-DOTATATE therapy, signifying that neoadjuvant PRRT can be considered in such patients. The effective control of symptoms, favorable morphologic and functional imaging response, and durable PFS and OS that we observed after 177Lu-DOTATATE PRRT may lead to less morbidity and mortality in these patients.

11.
Neuroendocrinology ; 111(10): 998-1004, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33017827

RESUMO

INTRODUCTION: Capecitabine-temozolomide (CAPTEM) chemotherapy, alone or with concurrent peptide receptor radionuclide therapy (PRRT), has activity in advanced WHO grade 2 and grade 3 neuroendocrine neoplasms (NENs). The objective of this study was to evaluate the activity of the CAPTEM in patients with grade 2 and grade 3 NENs and identify prognostic factors. MATERIALS AND METHODS: A retrospective analysis of patients with metastatic grade 2 and grade 3 NENs, who were having baseline significant dual uptake on 68Ga-DOTATATE/18F-fluorodeoxyglucose (FDG)-PET-CT scan and treated with CAPTEM chemotherapy between January 2014 and December 2019 at Tata Memorial Hospital, was conducted. The clinical variables and survival data were collected. Progression-free survival (PFS) was estimated using the Kaplan-Meier method. RESULTS: A total of 68 patients received the CAPTEM regimen, of whom 29 patients (43%) received CAPTEM alone and 39 patients (57%) received concurrent PRRT. The primary sites were pancreas in 32 (47%) and small intestine in 12 (18%) patients. Mean Ki-67 index was 12.6% (range: 3-50). Forty-five patients (65%) were treatment naïve. There were no significant differences in baseline clinical variables between patients treated with CAPTEM alone or with CAPTEM-PRRT. Both regimens were well tolerated. With a median follow-up of 22.1 months, the median PFS for the entire cohort was 27.5 months. There was no statistical difference in the median PFS between patients receiving CAPTEM alone or CAPTEM-PRRT (33.7 vs. 22 months; p = 0.199). A Ki-67 index of >5% predicted for inferior PFS on multivariate analysis (24 versus 73.8 months; p = 0.04; hazard ratio -3.77; 95% confidence interval: 1.07-13.26). CONCLUSION: CAPTEM, alone or concurrent with PRRT, has a significant activity in grade 2 and grade 3 NENs with dual SSTR and 18FDG expression. A Ki-67 index >5% predicts strongly for inferior outcomes and should be further explored as a prognostic cutoff in grade 2 NENs. Early initiation of CAPTEM should be considered in this group of tumors with significant baseline 18FDG expression.

12.
JAMA Oncol ; 7(3): 436-439, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33270098

RESUMO

Importance: There is therapeutic uncertainty regarding use of combination or single-agent chemotherapy in the treatment of patients with gallbladder cancer who experience disease progression after first-line chemotherapy. Objective: To compare the efficacy of capecitabine plus irinotecan (CAPIRI) vs irinotecan (IRI) alone in patients with advanced gallbladder cancer (GBC) who have disease progression after gemcitabine-based first-line treatment. Design, Setting, and Participants: The GB-SELECT trial was a multicenter, open-label, phase 2, randomized clinical trial of CAPIRI vs IRI alone for treatment of gallbladder cancer in patients who had disease progression after prior gemcitabine-based chemotherapy.The study was carried out in 2 tertiary care institutions in India. Patients aged between 18 and 70 years with histopathologic diagnosis of adenocarcinoma gallbladder, advanced or metastatic disease, previous treatment with gemcitabine-based chemotherapy, adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between August 2018 and January 2020. The data were analyzed for this report with cutoff on May 19, 2020. Interventions: Patients were randomized 1:1 to receive capecitabine, 1700 mg/m2 per day, on days 1 to 14 plus intravenous irinotecan, 200 mg/m2, on day 1 or intravenous irinotecan, 240 mg/m2, on day 1, in 21-day cycles until disease progression or unacceptable toxic effects. Main Outcomes and Measures: The primary end point was overall survival (OS) at 6 months. The secondary end points were progression-free survival and quality of life. Results: A total of 98 patients were randomized, 49 in each arm, with median (range) age of 51 (29-70) years, with 60 (61%) being women. In the CAPIRI vs IRI arms, the number of deaths at 6 months, 6-month OS, and median OS were 35, 34, 38.4% (95% CI, 24.2%-52.6%) and 5.16 (95% CI, 4.26-6.06) months vs 34, 29, 54.2% (95% CI, 39.4%-69.0%) and 6.28 (95% CI, 4.25-8.30) months, respectively, with a hazard ratio of 1.02 (95% CI, 0.64-1.49, P = .93). There were no chemotherapy-related deaths but more patients required dose modification in CAPIRI compared with the IRI arm (13 [27%] vs 4 [9%], respectively, P = .03). Conclusions and Relevance: There was no significant difference in OS between treatment with capecitabine plus irinotecan or irinotecan alone among previously treated patients with gallbladder cancer. Single-agent irinotecan should be the preferred treatment option for such patients. Trial Registration: CTRI/2017/10/010112.

13.
Asia Pac J Clin Oncol ; 17(2): e70-e76, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32030912

RESUMO

AIM: To study the outcomes of patients presenting with locally advanced rectal cancers with distant metastasis (mLARC), treated with short course radiotherapy (SCRT). METHOD: Between May 2012 and August 2015, 70 patients diagnosed with mLARC, treated with SCRT (25 Gy/5#) and three to six cycles of CAPOX chemotherapy (CT), were assessed for surgical feasibility for the primary and metastatic sites. RESULTS: Sixty-five patients could complete the planned SCRT and three to six cycles of CT. Response rate and disease control rate for the primary was 68% and 97%, respectively. Radiologically, CRM became free in 44 (72%) patients out of 61 initially involved. Fifty-two (74%) were planned to receive treatment with a potentially curative intent and 18 (26%) with palliative intent. Of those treated with curative intent, 34 (65%) underwent primary tumor resection (PTR). Successful intervention for metastatic disease was done in 27 (52%) patients. At a median follow up of 43 months, the median overall survival (OS) for patients undergoing PTR was 36 months versus 12 months for those in which the tumor was still unresectable or had distant progression (P < .001). Of the operated patients, 56% were alive at the end of 3 years. The median pelvic recurrence free survival was 29 months. Symptom control in the form of pain and bleeding control was observed in 80%. CONCLUSION: The addition of SCRT to CT in mLARC can downstage the primary tumor to undergo surgery, thereby, achieving better loco-regional control and survival. It achieves good palliation in patients unable to undergo surgery due to extensive primary or metastatic disease.


Assuntos
Neoplasias Retais/radioterapia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neoplasias Retais/patologia
14.
Eur J Nucl Med Mol Imaging ; 48(3): 913-923, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32876706

RESUMO

OBJECTIVE: The primary aims of this study were to evaluate the long-term outcome of a "sandwich chemo-PRRT (SCPRRT)" regimen with regard to therapeutic response rate, progression-free survival (PFS), and overall survival (OS) rates in metastatic neuroendocrine tumors (NETs) with both somatostatin receptor (SSTR)- and fluorodeoxyglucose (FDG)-avid aggressive disease. Additionally, health-related quality of life (HRQoL) scales, clinical toxicity, and association of PFS and disease control rate (DCR) with various variables were also evaluated. MATERIALS AND METHODS: A total of 38 patients of the aforementioned cohort, who received SCPRRT (at least 2 cycles of each PRRT and chemotherapy) at our institute between January 2012 and December 2018, were included and analyzed in this retrospective study. Between two cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT), two cycles of oral capecitabine and temozolomide (CAPTEM) were sandwiched. Therapeutic responses following SCPRRT were assessed by using pre-defined criteria. PFS and OS after first SCPRRT were determined. Eastern Cooperative Oncology Group (ECOG) and Karnofsky score were used for evaluation of HRQoL before and after SCPPRT in all 38 patients. Any adverse events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) of the National Cancer Institute. Associations of PFS and DCR with various variables were evaluated. RESULTS: Response (complete response and partial response) to SCPRRT was seen in 28 patients (73%), 15 patients (39%), and 16 patients (42%) on symptomatic, biochemical, and molecular imaging response evaluation criteria respectively. A total of 17 patients (45%) had anatomical imaging response with DCR of 84% based upon the RECIST 1.1 criteria. Pre-therapy mean ECOG and KPS was 2.0 and 68, which changed to 1.0 and 75 respectively following SCPRRT. Long-term follow-up data was available and ranged from 12 to 65 months after the first SCPRRT. Median PFS and OS were not reached at a median follow-up of 36 months. An estimated PFS rate of 72.5% and OS rate of 80.4% was found at 36 months. Longer PFS was dependent upon high SSTR uptake and number of CAPTEM cycle (≥ 7 cycles), absence of skeletal metastasis, and no previous external beam radiotherapy (EBRT) exposure with significant P value. Higher DCR was dependent upon absence of skeletal metastasis with significant P value. SCPRRT was tolerated well with none developing grade 4 hematotoxicity and nephrotoxicity of any grade. Anemia (grade 3), thrombocytopenia (grade 3), and leukopenia (grade 3) were noticed in 1 patient (2.5%), 2 patients (5%), and 1 patient (2.5%) respectively in this study. CONCLUSION: Thus, favorable response rates with effective control of symptoms and longer PFS and OS without high-grade or life-threatening toxicities were important observations in the present study following SCPRRT in NET patients with aggressive, both FDG- and SSTR-avid, metastatic progressive disease. The study results indicate the potential role of "sandwich chemo-PRRT" in future therapeutic algorithms of aggressive, both SSTR- and FDG-positive subset of neuroendocrine tumors.


Assuntos
Tumores Neuroendócrinos , Compostos Organometálicos , Fluordesoxiglucose F18 , Humanos , Tumores Neuroendócrinos/diagnóstico por imagem , Tumores Neuroendócrinos/tratamento farmacológico , Octreotida , Compostos Organometálicos/uso terapêutico , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Qualidade de Vida , Receptores de Somatostatina , Estudos Retrospectivos , Resultado do Tratamento
15.
Nucl Med Commun ; 42(3): 337-344, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33306631

RESUMO

OBJECTIVE: Patients with inoperable multilobar hepatocellular carcinoma (HCC) Barcelona Clinic Liver Cancer (BCLC) stage B, who have failed other liver-directed treatment options, are ideal candidates for transarterial radioembolization (TARE) with Yttrium-90 (Y-90)-labeled glass spheres. There is limited data regarding variables that impact the prognosis and outcome in these patients. 99mTc-MAA scan for lung shunt fraction (LSF) and 18F-FDG PET/CT are performed during initial workup. We, therefore, decided to assess the prognostic impact of LSF and metabolic parameters, such as maximum SUVmax, MTV and TLG in patients undergoing TARE for HCC. METHODS: We retrospectively analyzed 64 patients of HCC, between January 2010 and December 2016, deemed suitable for TARE. Pre-TARE LSF was computed on 99mTc MAA scan, and SUVmax, MTV and TLG on fluoro-deoxyglucose positron emission tomography/computed tomography were measured using automated software by 3D region of interest. LSF and PET parameters were stratified using optimal cut-offs derived from receiver operating curve analysis. Survival curves for the groups were estimated using the Kaplan-Meier method and were compared using log-rank test. RESULTS: Overall survival (OS) was 15 months. In univariate analysis, high LSF (greater than 7.19), MTV and TLG were statistically significant and were associated with poor OS. In multivariate analysis, TLG (P value 0.044), MTV (P value 0.290) and LSF (P value 0.010) were independent predictors of outcome, after adjustment for significant univariate variables. However, SUVmax was not statistically significant for OS. CONCLUSIONS: LSF, MTV and TLG are significant independent prognostic indicators of outcome in patients undergoing TARE for HCC.


Assuntos
Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/terapia , Embolização Terapêutica , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/terapia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Adulto , Idoso , Carcinoma Hepatocelular/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Prognóstico , Estudos Retrospectivos
16.
Cancer Med ; 9(23): 8747-8753, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33128509

RESUMO

BACKGROUND: There is limited data on outcomes in cancer patients with coronavirus disease 2019 (COVID-19) from lower middle-income countries (LMICs). PATIENTS AND METHODS: This was an observational study, conducted between 12 April and 10 June 2020 at Tata Memorial centre, Mumbai, in cancer patients undergoing systemic therapy with laboratory confirmed COVID-19. The objectives were to evaluate cumulative 30-day all-cause mortality, COVID-19 attributable mortality, factors predicting mortality, and time to viral negativity after initial diagnosis. RESULTS: Of the 24 660 footfalls and 7043 patients evaluated, 230 patients on active systemic therapy with a median age of 42 (1-75) years were included. COVID-19 infection severity, as per WHO criteria, was mild, moderate, and severe in 195 (85%), 11 (5%), and 24 (11%) patients, respectively. Twenty-three patients (10%) expired during follow-up, with COVID-19 attributable mortality seen in 15 patients (6.5%). There were no mortalities in the pediatric cohort of 31 (14%) patients. Advanced stage cancer being treated with palliative intent vs others [30-day mortality 24%% vs 5%, odds ratio (OR) 5.6, 95% CI 2.28-13.78, P < .001], uncontrolled cancer status vs controlled cancer (30-day mortality37.5%% vs 4%%, OR 14, 95% CI 4.46-44.16, P < .001) and severe COVID-19 vs mild COVID-19 (30-day mortality 71% vs 3%, OR 92.29, 95% CI 26.43-322.21, P < .001) were significantly associated with mortality. The median time to SARS-CoV-2 RT-PCR negativity was 17 days [interquartile range (IQR)17-28) in the cohort. CONCLUSIONS: The mortality rates in cancer patients with COVID-19 who are receiving systemic anti-cancer therapy in LMICSs are marginally higher than that reported in unselected COVID-19 cohorts with prolonged time to viral negativity in a substantial number of patients. The pediatric cancer patients tended to have favorable outcomes.


Assuntos
Antivirais/uso terapêutico , COVID-19/prevenção & controle , Neoplasias/terapia , SARS-CoV-2/efeitos dos fármacos , Adolescente , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/virologia , Criança , Pré-Escolar , Comorbidade , Feminino , Humanos , Índia/epidemiologia , Lactente , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Pandemias , Estudos Prospectivos , SARS-CoV-2/fisiologia , Taxa de Sobrevida , Adulto Jovem
17.
Am J Nucl Med Mol Imaging ; 10(4): 178-211, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32929396

RESUMO

The present treatise chronicles one decade of experience pertaining to clinical PRRT services in a large-volume tertiary cancer care centre in India delivering over 4,000 therapies, an exemplar of successful PRRT programme employing indigenous 177Lutetium production and resources. For the purpose of systematic discussion, we have sub-divided the communication into 3 specific parts: (a) Radiopharmaceutical aspects that describes 177Lutetium production through 'Direct' Neutron Activation Route and the subsequent radiolabeling procedures, (b) The specific clinical nuances and finer learning points (apart from the routine standard procedure) based upon clinical experience and how it has undergone practice evolution in our setting and (c) Dosimetry results with this indigenous product and radiation safety/health physics aspects involved in PRRT services. Initiated in 2010 at our centre, the PRRT programme is a perfect example of affordable quality health care delivery, with indigenous production of the radionuclide (177Lu) in the reactor and subsequent radiolabeling of the radiopharmaceutical ([177Lu]Lu-DOTATATE) at the hospital radiopharmacy unit of the centre, which enabled catering to the needs of a large number of patients of progressive, metastatic and advanced Neuroendocrine Neoplasms (NENs) and related malignancies.

18.
Oncologist ; 25(12): e1886-e1892, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32717127

RESUMO

LESSONS LEARNED: A structured teaching module including intensive prophylactic measures to alleviate hand-foot syndrome (HFS) during capecitabine therapy is feasible but ineffective at protecting patients from HFS. Pharmacologic therapeutic interventions should be investigated for the management of this complication. BACKGROUND: Capecitabine-induced hand-foot syndrome (HFS) has a detrimental effect on quality of life. The effect of a structured teaching module including intensive prophylactic measures was evaluated. METHODS: This non-crossover phase III double-blinded clinical trial randomized patients in a 1:1 ratio to either a control group or to a group administered a structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control). The primary endpoint was comparison of fraction of patients in both arms developing at least grade 2 HFS. RESULTS: Between June 15, 2016, and April 4, 2018, 280 patients (140 to case and 140 to control) were enrolled. The median number of capecitabine chemotherapy cycles was eight; 269 patients (96%) were evaluable for HFS, of whom 89 patients (33.08%) developed at least grade 2 HFS (grade 2 HFS, 73 patients [26.1%]; grade 3 HFS, 16 patients (5.7%}). There was no difference in at least grade 2 HFS between evaluable case and control arms of the study (control group, 45/135 [33.3%]; case, 44/134 [32.8%]; p = .93). CONCLUSION: The use of a structured teaching module including intensive prophylactic measures was feasible, but this did not reduce the incidence and severity of capecitabine-induced HFS.


Assuntos
Síndrome Mão-Pé , Capecitabina/efeitos adversos , Fluoruracila , Síndrome Mão-Pé/epidemiologia , Síndrome Mão-Pé/etiologia , Síndrome Mão-Pé/prevenção & controle , Humanos , Incidência , Estudos Prospectivos , Qualidade de Vida
19.
J Gastrointest Cancer ; 51(2): 703-708, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31956953

RESUMO

INTRODUCTION: Data regarding long-term survival and prognosis in loco-regionally advanced, non-metastatic gastric cancers (GC) using perioperative chemotherapy and D2 lymphadenectomies from India is scarce. MATERIALS AND METHODS: The study is a retrospective evaluation of locally advanced gastric cancers who received epirubicin-oxaliplatin-capecitabine (EOX) as perioperative therapy from May 2013 to December 2015 at Tata Memorial Hospital, Mumbai. The report concentrates on long-term survival outcomes and prognostic factors. Event-free survival (EFS) and overall survival (OS) were calculated using Kaplan-Meier method. RESULTS: Two hundred and sixty-eight patients were started on EOX regimen, of which 200 patients (74.6%) underwent definitive resection with D2 lymphadenectomy. With a median follow-up of 52.7 months, the estimated median 3-year and 5-year EFS were 38.5% and 36.3% respectively. The estimated median 3-year and 5-year OS were 41.7% and 37.6% respectively. Patients younger than age 40 years [HR 1.55 (1.034-2.321); p = 0.034] and with poorly differentiated histology [HR 0.65 (0.446-0.944); p = 0.024] had inferior OS compared to their counterparts. CONCLUSIONS: Long-term OS in Indian patients in non-metastatic GC with EOX chemotherapy and D2 lymphadenectomy is similar to previously published Western data. Younger Indian patients fare worse than their older counterparts and this needs further evaluation.


Assuntos
Gastrectomia/métodos , Compostos Organoplatínicos/uso terapêutico , Neoplasias Gástricas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Neoplasias Gástricas/mortalidade , Neoplasias Gástricas/patologia , Análise de Sobrevida , Adulto Jovem
20.
HPB (Oxford) ; 22(3): 376-382, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31405778

RESUMO

BACKGROUND: Evidence suggests that intestinal type (IT) and pancreatobiliary (PB) subtypes of ampullary adenocarcinoma (AC) may have different outcomes. The current study evaluated differences in outcomes between these subtypes and the benefit of adjuvant chemotherapy (AT). METHODS: A prospectively maintained database of patients who underwent upfront resection for AC from January 2012 to March 2016 was conducted. A dedicated pathologist reported differentiation between IT and PB subtypes. RESULTS: 214 patients were included for analysis: 105 PB subtype and 109 IT subtype. With a median follow up of 46.3 months, estimated 4 year overall survival (OS) was 65.8%. In patients with stage II-III disease, lymph-node ratio (LNR) < 0.2 [Not reached (NR) vs. 30.72 months; p = 0.002], absence of perineural invasion (PNI) (NR vs. 31.61 months; p = 0.032) and AT (gemcitabine - 96.1%) (NR vs. 22.28 months) were prognostic for superior OS. There was no difference in OS between IT and PB subtypes, but both subtypes with stage II-III disease benefitted from AT statistically as compared to observation (IT: NR vs. 28.62 months; PB: 18.46 months vs. 58.09 months; p < 0.001). CONCLUSIONS: AC-IT and AC-PB did not have a different OS when treated with resection and adjuvant gemcitabine, though adjuvant therapy benefitted both subtypes individually.


Assuntos
Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Ampola Hepatopancreática , Neoplasias do Ducto Colédoco/mortalidade , Neoplasias do Ducto Colédoco/patologia , Desoxicitidina/análogos & derivados , Adenocarcinoma/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antimetabólitos Antineoplásicos/administração & dosagem , Quimioterapia Adjuvante , Neoplasias do Ducto Colédoco/cirurgia , Desoxicitidina/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
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