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1.
Int J Cancer ; 2021 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-34751432

RESUMO

The real-world data on short-course of ICI use is sparse and merits exploration. A multi-centric observational study on the safety and efficacy of ICI in oncology patients between August 2014 to October 2020 involving 1011 patients across 13 centers in India. The median age was 59 (min 16- max 98) years with male preponderance (77.9%). The predominant cohort received short-course ICI therapy; the median number of cycles were 5 (95% CI 1 - 27) and median duration of therapy was 3 (95% CI 0.5 - 13) months. ICI were used commonly in second and third line setting in our study (66.4%, n=671). Objective response rate (ORR) (complete or partial response) was documented in 254 (25.1%) of the patients, 202 (20.0%) had stable disease and 374 (37.0%) had progressive disease. The clinical benefit rate was present in 456 (45.1%). Among the patients whom ICI was stopped (n=906), the most common reason for cessation of ICI was disease progression (616, 68.0%) followed by logistic reasons like financial constraints (234, 25.82%). With a median follow up of 14.1 (95%CI 12.9-15.3) months, there were 616 events of progression and 443 events of death and the median progression free survival and overall survival were 6.4 (95%CI 5.5-7.3) and 13.6 (95%CI 11.6-15.7) months respectively in the overall cohort. Among the immune related adverse events (irAEs), autoimmune pneumonitis (29, 3.8%) and thyroiditis (24, 2.4%) were common. Real-world multicentric Indian data predominantly with short-course ICI therapy, has comparable efficacy/safety to international literature with standard ICI therapy. This article is protected by copyright. All rights reserved.

3.
Ecancermedicalscience ; 15: 1274, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34567259

RESUMO

Background: A significant proportion of non-small cell lung cancer (NSCLC) patients present with poor performance status (PS) at baseline are almost always excluded from the clinical trials leading to availability of only limited data in this subgroup. Patients and methods: This was an observational single institutional study. The eligibility criteria for inclusion were a histologic or cytologic diagnosis of advanced NSCLC and Eastern Cooperative Oncology Group PS 3 or 4. All patients coming between June 2015 and December 2018 were evaluated for inclusion in this study. Results: A total of 245 patients were enrolled in the study. The median age of the patients was 63 years (range 25-89), 142 (58%) were male, 196 (80%) had adenocarcinoma histology and 192 (78.4%) has PS 3 while rest (21.6%) had PS 4. Out of 245 patients, 192 (78.4%) received oral tyrosine kinase inhibitors (TKI) and supportive care, 45 (18.4%) received supportive care alone, while 8 (3.2%) patients received chemotherapy along with supportive care. Median overall survival (OS) was 3 months (95% CI: 1.8-4.2) in patients who received oral TKI versus 1 month (1.0-2.9) in patients who received supportive care alone (log-rank p = 0.013). The median OS for epidermal growth factor receptor (EGFR) mutant patients who received oral TKI was 12 months (95% CI: 7.7-16.3), while it was 3 months (95% CI: 1.5-4.5) for patients who were EGFR wild-type and received TKI on compassionate basis (HR = 0.50; 95% CI: 0.32-0.77; p = 0.001). Conclusions: The use of oral TKI on a compassionate basis led to improvement in survival in the overall cohort of the patients; this was principally driven by EGFR-mutated patients.

4.
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.
South Asian J Cancer ; 10(2): 92-96, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34568222

RESUMO

Introduction TFE Translocation renal cell carcinoma (TRCC) represents 1 to 5% of all cases of renal cell carcinoma, with the highest frequency among children and young adults. Management of these tumors is not very well defined in literature. Although in pediatric age group it has favorable prognosis, in adults it has an aggressive nature, with poor outcome. This is a retrospective analysis of treatment outcome in adult patient 18 years or above treated at our hospital between January 2013 and November 2018. Material and Methods Clinical and pathological data of 26 patients from a single institution diagnosed with TRCC between January 2013 and November 2018 were retrospectively reviewed. All cases of TRCC were confirmed with immunohistochemistry or fluorescence in situ hybridization. We analyzed our data of patients treated with surgery only or who progressed after surgery and treated with systemic therapy or who presented with upfront unresectable or metastatic disease treated with systemic therapy with respect to event-free survival (EFS) and overall survival (OS). Results Between January 2013 and November 2018, 26 adult patients who were treated at our center were eligible for this analysis as per our criteria. Out of 26 patients, 25 patients had radical surgery after evaluation and 1 had metastatic disease who was started on systemic therapy. Out 25 patients who were treated with radical surgery, 16 patients progressed and they were started on systemic therapy except for 1 patient who defaulted. Median time to start systemic therapy among patient treated with curative nephrectomy was 13 months. Median EFS and median OS among overall population were 22 and 30 months, respectively. Among 16 patients who were treated with systemic therapy, median EFS to first-line therapy was 8 months and to second-line therapy was 2.5 months. Median OS was 17 months in patients treated with systemic therapy. Conclusion TRCC is rare in adult population but carries significant risk of disease progression even after initial curative treatment with potential response to targeted therapy for short duration.

6.
Cancer Med ; 10(19): 6725-6735, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34498421

RESUMO

BACKGROUND: There are limited data from low- to middle-income countries (LMIC) on the incidence, risk factors, treatment outcomes, and antibiotic susceptibility spectrum of aspiration pneumonia (AsP). METHODS: We conducted a post hoc analysis of a randomized control trial in which adult patients with locally advanced head and neck cancers had received 66-70 Gy of radiation combined with cisplatin 30 mg/m2 weekly for 6-7 weeks or cisplatin at the same dose with nimotuzumab 200 mg once weekly till the completion of radiation. The following data were extracted and analyzed-the incidence of AsP, time to the onset of AsP, risk factors, treatment outcomes of AsP, and its impact on progression-free survival (PFS), locoregional control (LRC) rates, and overall survival (OS). RESULTS: Out of 536 patients enrolled in the study, 151 (28.3%, 95% confidence interval [CI] 24.5-2.1) patients developed AsP. The median time to develop AsP was 39 days (95% CI 34-44). Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP. Among the patients in which pathogenic organism was isolated (69 patients), gram-negative species was isolated in 63 patients (89%). Cisplatin at 200 mg/m2 or more was delivered in 312 (81%) patients in the non-AsP cohort versus 107 (70.9%) patients in AsP cohort (p = 0.014). There was no statistical difference in LRC (hazard ratio [HR] = 1.057; 95% CI 0.771-1.448), PFS (HR = 1.176; 95% CI 0.89-1.553), and OS (HR = 1.233; 95% CI 0.939-1.618) between the two cohorts. CONCLUSION: Aspiration pneumonia is a common complication in head and neck malignancies and patients with baseline dysphagia are at high risk. Gram-negative bacteria are the predominant causative agents. The use of broad-spectrum antibiotics results in resolution of symptoms.

7.
Oral Oncol ; 122: 105517, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34560383

RESUMO

INTRODUCTION: The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial. METHODS: In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL. RESULTS: 536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms. CONCLUSION: The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.

8.
Oral Oncol ; 122: 105522, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34571463

RESUMO

BACKGROUND: Weight loss during chemotherapy and its impact on the cancer outcomes have been invariably reported in the literature. We also did a post-hoc analysis of a randomized phase III trial to see the same. MATERIALS AND METHODS: The database of a recently published randomized study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation was used for this analysis. Week-wise weight loss during the course of treatment was noted. The impact of severe weight loss (grade 2-3) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan Meier method. Binary logistic regression analysis was used to see the effect of various factors. RESULTS: Out of a total of 536 patients, weight loss was captured in 524. Out of these 524 patients, any degree of weight loss was seen in 293 (55.91%) patients. Grade 1 weight loss was noted in 192 (36.6%) patients, grade 2 in 96 (18.3%) and grade 3 in 5 (1%) patients. The 2-year PFS was 53% and 57.1% in severe and non-severe weight loss groups respectively (p-value = 0.36). The 2-year LRC was 60% in patients with severe weight loss, while it was 63.5% in those with non-severe weight loss (p-value = 0.47). The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21). None of the factors was found to be associated with severe weight loss. CONCLUSION: Severe weight loss was uncommon in our patients. Weight loss during treatment was not associated with poor survival outcomes.

9.
Expert Opin Pharmacother ; 22(15): 2007-2018, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34187268

RESUMO

Introduction: Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers worldwide and is a leading cause for cancer-related mortality. This review attempts to give a comprehensive summary of the recent developments in pharmacotherapeutic options for locally advanced/metastatic HNSCC.Areas covered: In this review, the authors conducted a systematic literature search for published articles on HNSCC in the PubMed database using the keywords 'head and neck squamous cell carcinoma or HNSCC,' 'targeted therapy,' 'immunotherapy.' The search was restricted to meta-analyses, clinical trials, practice guidelines, and abstract presentations at international meetings. The final search encompassed articles published from 2010 to 2021. Articles published in languages other than English were excluded.Expert opinion: Immune checkpoint inhibition has been the most significant advance in the treatment of R/M HNSCC. Oral metronomic therapy has emerged as an important therapeutic option for low to middle-income countries. H-RAS inhibition is one of the most promising areas of research.


Assuntos
Neoplasias de Cabeça e Pescoço , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Humanos , Fatores Imunológicos , Imunoterapia , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico
10.
J Egypt Natl Canc Inst ; 33(1): 12, 2021 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-34021843

RESUMO

BACKGROUND: Acute oral mucositis has been infrequently studied in the patients with head and neck squamous cell carcinoma (HNSCC) receiving once-weekly cisplatin-based chemoradiotherapy (CRT). Hence, this analysis was conducted to explore the various aspects of the same. RESULTS: The overall incidence of mucositis was 96.9% (n = 508) and of grade 3-5 mucositis was 61.3% (n = 321). The overall incidence of oral mucositis was similar in both the arms (CCRT and NCRT) (p value = 0.58) while grade 3-5 mucositis was more common in the NCRT arm (p value = 0.01). Out of all factors listed, the presence of nimotuzumab was the only significant risk factor for the development of grade 3 or more oral mucositis (p value = 0.01); (OR = 1.64, 95%CI 1.15-2.32). Delays in the treatment delivery were similar in both the arms. CONCLUSION: Acute oral mucositis is a common occurrence in locally advanced-HNSCC patients receiving chemoradiotherapy. Nimotuzumab is a significant factor for development of grade 3 and above oral mucositis.


Assuntos
Neoplasias de Cabeça e Pescoço , Estomatite , Anticorpos Monoclonais Humanizados , Quimiorradioterapia/efeitos adversos , Cisplatino/efeitos adversos , Neoplasias de Cabeça e Pescoço/terapia , Humanos , Estomatite/induzido quimicamente , Estomatite/epidemiologia
11.
Pediatr Blood Cancer ; 68(9): e29081, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33991401

RESUMO

BACKGROUND: Outcome and toxicity data in adolescent-adult Ewing sarcoma (AA-ES) patients are sparse and merits exploration. METHODS: Histopathologically confirmed, nonmetastatic AA-ES patients, who received standard institutional combination chemotherapy regimen (Ewing's family of tumors-2001 [EFT-2001]) comprising of ifosfamide plus etoposide and vincristine, doxorubicin plus cyclophosphamide, lasting a total of 12 months between 2013 and 2018, were analyzed for treatment-related toxicities, event-free survival (EFS), and overall survival (OS). RESULTS: There were 235 patients (primary safety cohort [PSC]) with median age of 23 (15-61) years; 159 (67.7%) were males, 155 (65.9%) had skeletal primary and 114 (48.5%) had extremity tumors. One hundred ninety-six (83.4%) were treatment naïve (primary efficacy cohort [PEC]) and of these 119 (60.7%) had surgery. In PEC, at a median follow-up of 36.4 (interquartile range [IQR] 20-55) months, estimated 3-year EFS and OS were 67.3% (95% CI 60.3-75.1%) and 91.1% (95% CI 86.7-95.7%), respectively. Of these, 158 (80.6%) complying with intended treatment, at a median follow-up of 39 (IQR 26-57) months had an estimated 3-year EFS of 68.2% (95% CI 60.3-76.1%). In multivariable analysis, good prognostic factors included longer symptom(s) duration (HR 0.93, 95% CI 0.86-0.994), ≥99% necrosis (HR 0.30, 95% CI 0.11-0.77), and treatment completion (HR 0.32, 95% CI 0.14-0.74). Among PSC, grade 3-4 toxicities were febrile neutropenia (119, 50.6%), anemia (130, 55.3%), peripheral neuropathy (37, 15.7%), with three (1.3%) chemo-toxic deaths. CONCLUSIONS: The outcomes of AA nonmetastatic ES patients treated with EFT-2001 regimen were comparable to those reported by others, with acceptable toxicity. This regimen can be considered a standard of care in AA-ES.

12.
Oncotarget ; 12(6): 578-588, 2021 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-33796225

RESUMO

INTRODUCTION: Unlike lung adenocarcinoma patients, there is no FDA-approved targeted-therapy likely to benefit lung squamous cell carcinoma patients. MATERIALS AND METHODS: We performed survival analyses of lung squamous cell carcinoma patients harboring therapeutically relevant alterations identified by whole exome sequencing and mass spectrometry-based validation across 430 lung squamous tumors. RESULTS: We report a mean of 11.6 mutations/Mb with a characteristic smoking signature along with mutations in TP53 (65%), CDKN2A (20%), NFE2L2 (20%), FAT1 (15%), KMT2C (15%), LRP1B (15%), FGFR1 (14%), PTEN (10%) and PREX2 (5%) among lung squamous cell carcinoma patients of Indian descent. In addition, therapeutically relevant EGFR mutations occur in 5.8% patients, significantly higher than as reported among Caucasians. In overall, our data suggests 13.5% lung squamous patients harboring druggable mutations have lower median overall survival, and 19% patients with a mutation in at least one gene, known to be associated with cancer, result in significantly shorter median overall survival compared to those without mutations. CONCLUSIONS: We present the first comprehensive landscape of genetic alterations underlying Indian lung squamous cell carcinoma patients and identify EGFR, PIK3CA, KRAS and FGFR1 as potentially important therapeutic and prognostic target.

13.
Head Neck ; 43(7): 2045-2057, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33687114

RESUMO

BACKGROUND: To assess the efficacy of intensity-modulated radiation therapy (IMRT) for tumors of the nasal cavity and paranasal sinus (PNS) region. MATERIALS AND METHODS: Two hundred fourteen patients with tumors of the nasal cavity and PNS region treated with curative intent IMRT between 2007 and 2019 were included in this retrospective analysis. RESULTS: Fifty-one (24.1%) received definitive RT/CTRT and 163 (75.9%) received adjuvant RT. Most common histology was squamous cell carcinoma (26.1%) followed by adenoid cystic carcinoma (21.5%). The median follow-up was 43.5 months. The 5-year local control (LC), event-free survival (EFS), and overall survival (OS) for the entire cohort was 66.9%, 59%, and 73.9%, respectively. On univariate analysis treatment with nonsurgical modality, T classification and undifferentiated/poorly differentiated histology were associated with inferior 5-year LC, EFS, and OS. Four patients had late Grade 3/Grade 4 ocular toxicity. CONCLUSIONS: IMRT should be the standard of care for tumors of PNS region across all histologies and treatment setting.


Assuntos
Neoplasias Nasais , Neoplasias dos Seios Paranasais , Radioterapia de Intensidade Modulada , Humanos , Cavidade Nasal , Neoplasias Nasais/radioterapia , Neoplasias dos Seios Paranasais/radioterapia , Dosagem Radioterapêutica , Radioterapia de Intensidade Modulada/efeitos adversos , Estudos Retrospectivos
14.
Ecancermedicalscience ; 15: 1166, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33680080

RESUMO

Background: Multiple low-cost biosimilars of bevacizumab are now available but their clinical efficacy has never been compared against the original (innovator) molecule in glioblastoma. The aim of the current analysis is to compare the overall survival (OS) in recurrent/progressive glioblastoma patients between the biosimilar and innovator molecules. Materials and methods: Adult recurrent/progressive glioblastoma patients treated with bevacizumab from 1 July 2015 to 30 July 2019 were identified. These patients were either offered Bevacizumab innovator (Avastin, Roche) or biosimilar (BevaciRel: Reliance Life sciences or Bryxta: Zydus Oncosciences) depending upon the financial status and affordability of the patients. The primary endpoint of the study was OS, while progression-free survival (PFS) and adverse events were the secondary endpoints. Results: There were 82 patients, out of which 57 received innovator and 25 received biosimilar bevacizumab. At median follow-up of 26 months, the median PFS was 3.66 (95% confidence interval (CI) 2.08 to 5.25) and 3.3 months (95% CI 2.38 to 4.21) in innovator and biosimilar group, respectively (Log-rank test p-value = 0.072). The hazard ratio (HR) for progression was 0.61 (95% CI 0.35 to 1.05; p-value = 0.075). At the time of data cut-off, the median OS was 5.53 (95% CI, 5.07 to 5.99) versus 7.33 months (95% CI, 5.63 to 9.03) in innovator and biosimilar group, respectively (Log-rank test p-value = 0.51). The HR for death was 1.21 (95% CI, 0.67 to 2.17; p-value = 0.51). The adverse events and safety profiles were comparable between the two groups. Conclusion: In the recurrent/progressive glioblastoma patients, both innovator and biosimilar bevacizumab seem to have similar safety and clinical efficacy.

15.
Medicine (Baltimore) ; 100(13): e25115, 2021 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-33787593

RESUMO

ABSTRACT: Immune checkpoint inhibitors (ICIs) are rapidly being incorporated as treatment option either alone or in combination with chemotherapy in most of the solid tumors. Since there is very limited data of ICI in patients with poor performance status (PS) from the real world settings, we performed a retrospective audit of patients who received ICI and report the analysis based on ECOG PS of these patients.This study is a retrospective audit of a prospectively collected database of patients receiving ICIs for advanced solid tumors in any line between August 2015 and November 2018 at Tata Memorial Hospital, Mumbai, India. All statistical calculations were performed using SPSS statistical software for windows version 20.0.A total of 155 patients who received ICIs during the specified period were evaluated for this study. Baseline ECOG PS 0-1 (n = 103, 66.4%) patients was associated with median OS 9.1 (95% CI [confidence interval], 4.4-NR) months when compared to ECOG 2-4 (n = 52, 33.5%) which had a median OS of 2.9 (95% CI; 1.8-5.5) months (HR, 1.7, 95% CI, 1.1-2.7, log rank P = .017). The disease control rate for the poor PS group was 34.6%. However, 27.3% patients (95% CI: 20.3-34.3) were still alive at 1 year. Median OS in patients with PS 2 was 3.7 months (95% CI: 0-11.6) as compared to 1.8 months (95% CI: 0.2-3.4) for those with PS 3-4 (HR-2.0; 95% CI: 1.0-3.9, P = .041). The tolerance to ICIs was good with no grade 3/4 toxicities in 44 (84.6%) patients.Immune checkpoint inhibitors are a safe and effective therapeutic option even in solid tumor patients with poor performance status.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Inibidores de Checkpoint Imunológico/uso terapêutico , Oncologia/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Neoplasias/mortalidade , Bases de Dados Factuais , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento
16.
J Natl Cancer Inst ; 113(9): 1228-1237, 2021 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-33606023

RESUMO

BACKGROUND: Early palliative care (EPC) is an important aspect of cancer management but, to our knowledge, has never been evaluated in patients with head and neck cancer. Hence, we performed this study to determine whether the addition of EPC to standard therapy leads to an improvement in the quality of life (QOL), decrease in symptom burden, and improvement in overall survival. METHODS: Adult patients with squamous cell carcinoma of the head and neck region planned for palliative systemic therapy were allocated 1:1 to either standard systemic therapy without or with comprehensive EPC service referral. Patients were administered the revised Edmonton Symptom Assessment Scale and the Functional Assessment of Cancer Therapy for head and neck cancer (FACT-H&N) questionnaire at baseline and every 1 month thereafter for 3 months. The primary endpoint was a change in the QOL measured at 3 months after random assignment. All statistical tests were 2-sided. RESULTS: Ninety patients were randomly assigned to each arm. There was no statistical difference in the change in the FACT-H&N total score (P = .94), FACT-H&N Trial Outcome Index (P = .95), FACT-general total (P = .84), and Edmonton Symptom Assessment Scale scores at 3 months between the 2 arms. The median overall survival was similar between the 2 arms (hazard ratio for death = 1.01, 95% confidence interval = 0.74 to 1.35). There were 5 in-hospital deaths in both arms (5.6% for both, P = .99). CONCLUSIONS: In this phase III study, the integration of EPC in head and neck cancer patients did not lead to an improvement in the QOL or survival.

17.
Cancer Med ; 10(5): 1525-1534, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33591635

RESUMO

BACKGROUND: Checkpoint inhibitors (Nivolumab and Pembrolizumab) are approved for multiple indications in solid tumors. However access to these therapies is limited in low and middle income countries. Hence we performed an audit to identify accessibility, adverse event rates, compliance, progression free survival and overall survival in solid tumors. METHODS: This was a single center retrospective analysis of prospective data base of patients with non-melanoma solid tumors who were treated with immunotherapy from August 2015 to November 2018. Adverse events during immunotherapy were documented and graded using CTCAE (Common terminology criteria for adverse events), v. 4.02. The response rates to immunotherapy, toxicities and the time to onset and resolution of toxicities were also evaluated as secondary endpoints. RESULTS: Out of 9610 patients, only 155 patients (1.61%) could receive immunotherapy. The most common malignancies included metastatic non-small cell lung cancer, metastatic renal cell carcinoma, metastatic urothelial carcinoma and relapsed/recurrent head and neck squamous cell carcinoma. Median overall survival in patients who received immunotherapy in non-melanoma solid malignancies was 5.37 months (95% CI, 3.73-9.73). Poor performance status at baseline was the only adverse prognostic factor. The median progression free survival was 2.57 months (95% CI, 1.73-3.83). Immunotherapy was well tolerated with most common side effects being fatigue 14.8% and anorexia 5.8%. The cumulative incidence of immune related adverse events like hepatitis, pneumonitis, colitis and nephritis was less than 10%. CONCLUSION: Real-world data in Indian setting confirms the benefit of immunotherapy in patients with advanced non-melanoma solid tumors.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Inibidores de Checkpoint Imunológico/uso terapêutico , Imunoterapia Adotiva/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Nivolumabe/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anorexia/induzido quimicamente , Anticorpos Monoclonais Humanizados/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/mortalidade , Fadiga/induzido quimicamente , Feminino , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Neoplasias de Cabeça e Pescoço/mortalidade , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Inibidores de Checkpoint Imunológico/provisão & distribuição , Índia , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/mortalidade , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Nivolumabe/efeitos adversos , Intervalo Livre de Progressão , Estudos Retrospectivos , Carcinoma de Células Escamosas de Cabeça e Pescoço/tratamento farmacológico , Carcinoma de Células Escamosas de Cabeça e Pescoço/mortalidade , Adulto Jovem
18.
Eur Arch Otorhinolaryngol ; 278(9): 3401-3407, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33388992

RESUMO

BACKGROUND: Bleeding from the unsalvageable recurrent and metastatic head and neck cancer is not an uncommon occurrence. It is extremely distressing for the patients and their family members and also to the treating doctors. One of the ways to manage this crisis is by selective embolization of the bleeding vessel. METHODOLOGY: In this retrospective study, we audited the patients with unresectable, unsalvageable recurrent and/or metastatic head and neck cancer who underwent selective (palliative) embolization for bleeding at our institute between Jan 2015 and Nov 2019, and assessed its possible benefit in terms of bleeding free interval achieved. RESULTS: Twenty-six palliative embolization was done during the above mentioned period. The majority were male patients (n = 23, 88.4%) with a median age of 54.5 years. The performance status (PS) of most patients was 2 (n = 15, 57.6%). The most common bleeding vessel was the external carotid artery or one of its branches, most commonly lingual artery (n = 5). The bleeding vessel was identified and embolized with PVA/gel foam/coil/glue. All the procedures were uneventful. Out of 26 patients, 3 patients had another bleeding episode subsequently. Most patients had 20 days to 21 months of bleeding free interval. The cost involved in the procedure was between 400 and 2100 US dollars. CONCLUSIONS: Selective embolization is an option to be considered in certain patients with unresectable, unsalvageable recurrent and/or metastatic head and neck cancer, when they present with sudden and massive bleeding to the emergency department, at centres where the facility and expertise for this procedure might be available.


Assuntos
Embolização Terapêutica , Neoplasias de Cabeça e Pescoço , Feminino , Neoplasias de Cabeça e Pescoço/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/terapia , Estudos Retrospectivos , Resultado do Tratamento
19.
Eur Arch Otorhinolaryngol ; 278(8): 3011-3018, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33165732

RESUMO

INTRODUCTION: Laryngeal and hypopharyngeal carcinoma are among the common head and neck cancers causing considerable swallowing dysfunction. The functional status of the organ (larynx) is an important point of contention while considering the patients for organ preservation protocol. METHODOLOGY: The aim of this retrospective study was to assess the swallowing status in stage III/IV laryngeal and hypopharyngeal carcinoma and its influence on treatment decision. We evaluated all treatment naïve patients who were referred to the swallowing clinic in 2017 (Jan-Dec) for assessment of swallowing prior to treatment initiation. RESULTS: One hundred patients satisfied the eligibility criteria and were included in the study. The site and stage of laryngeal and hypopharyngeal cancer cases were almost equal in number. Their median age was 58 years. Fiberoptic endoscopic evaluation of swallowing (FEES) was done in all patients. 30% of the patients only had swallowing difficulties. Only advanced T-stage (p = 0.04) had an influence on the pretreatment swallowing status. Thirty-seven patients required nasogastric tube (NGT) for feeding. By 2 month post-treatment completion, most patients on NGT could resume oral feeding. CONCLUSIONS: Pretreatment swallowing assessment alone did not significantly seem to influence our decisions for organ preservation treatment. However, patients with aspiration could be identified and managed appropriately. Most patients on NGT could resume oral feeds post-treatment completion.


Assuntos
Transtornos de Deglutição , Neoplasias Hipofaríngeas , Laringe , Deglutição , Transtornos de Deglutição/diagnóstico , Transtornos de Deglutição/etiologia , Humanos , Neoplasias Hipofaríngeas/complicações , Neoplasias Hipofaríngeas/terapia , Pessoa de Meia-Idade , Estudos Retrospectivos
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