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Background: Sleep quality in cancer patients often does not receive sufficient attention from their treating physicians and nurses. This report aims to highlight this under-researched issue among colorectal cancer patients scheduled to receive adjuvant chemotherapy. Materials and Methods: This is a secondary analysis of data from 129 participants from a randomized controlled trial conducted to determine the nurse-led intervention’s effect on cognitive and non-cognitive functions and serum TNF-alpha levels in patients receiving chemotherapy for colorectal cancer at Tata Memorial Hospital. The Pittsburgh Sleep Quality Index was used to collect data on sleep quality. The study also explored potential reasons for the reported poor sleep quality in the selected cohort. Results: The prevalence of poor sleep quality was approximately 60%. Sleep was primarily affected due to poor sleep latency and sleep efficiency. Also, women were more likely to experience issues related to sleep. Patients did not consider it a significant issue to report to their treating physicians and nurses. Factors contributing to poor sleep quality included financial concerns, child-rearing responsibilities, and anxiety about disease outcomes. Conclusion: Cancer patients do experience poor sleep quality, and it is crucial to assess and address this issue promptly to prevent adverse responses to cancer therapy, which can lead to increased morbidity and mortality.

PURPOSEStandard-dose immune checkpoint inhibitors (SD-ICIs) are the standard of care as initial therapy in microsatellite instable-high (MSI-H) advanced/metastatic colorectal adenocarcinomas (mCRC), but there are preclinical data to suggest that low-dose ICIs (LD-ICI) might also have similar efficacy.MATERIALS AND METHODSA retrospective study of patients with MSI-H mCRC receiving ICIs between June 2017 and January 2023 was conducted. The primary end point of the study was 12-month progression-free survival (PFS), which was computed using the Kaplan-Meier method.RESULTSA total of 65 patients were available for analysis during the study period. Sixty patients (92%) received nivolumab, whereas the remaining received pembrolizumab. First-line ICIs were received by 18 patients (28%), whereas 47 patients (72%) received ICIs during later lines. Thirty patients (47%) received LD-ICIs (all received nivolumab), with the remaining receiving SD-ICIs (53%). At a median follow-up of 16.5 (95% CI, 11.8 to 21.2) months, median PFS was not reached in the entire cohort. The 12-month PFS rate in the LD-ICI cohort was 90%, whereas it was 75.8% in the SD-ICI cohort. There were no statistical differences in patients receiving ICIs as first-line therapy (12 months PFS—94.4%) or during later lines of therapy (12-month PFS—77.9%; P = .56).CONCLUSIONICIs in the current study show survivals which are similar to those seen in seminal trials in patients with MSI-H mCRC. Low-dose ICIs appear to work in MSI-H mCRC and should be explored prospectively in clinical trials. Patients with MSI-H status should be exposed to ICIs, whether initially or later during treatment, whenever feasible.

Objective Older patients with cancer have traditionally been under-represented in global clinical trials. There are no data from India regarding this issue.Methods and analysis This was a retrospective analysis done at our institute on interventional studies conducted between 2003 and 2023 in adult patients with malignancies. We excluded studies done exclusively in the paediatric population and observational studies.Results We included 21 894 patients enrolled in 150 interventional trials from the departments of surgical, medical, and radiation oncology, anaesthesia, and clinical pharmacology; 110 (73.3%) were investigator initiated. There were 38 trials (25.3%) in breast cancer (6141 patients, 28%), and 33 (22%) in head and neck cancer (6975 patients, 31.9%). Studies were predominantly phase III (97 trials (64.7%)). Multicentric studies comprised approximately one-third (48, 32%). The median age of enrolled patients was 51 years (IQR 43–59). There were 5132 (23.4%) participants aged ≥60 years, 2678 (12.2%) ≥65 years and 1045 (4.8%) ≥70 years. Data from the hospital registry revealed that 30% of adult registrations were ≥60 years. There was a significant increase in the proportion of older patients enrolled in clinical trials from 2003 (8%) to 2019 (22%) compared with their proportion in the hospital registry (stable at 28%–29%); p

PURPOSEDesmoid fibromatosis (DF) is a locally aggressive tumor with low mortality but significant morbidity. There is a lack of standard of care, and existing therapies are associated with significant barriers including access, cost, and toxicities. This study aimed to explore the efficacy and safety of the metronomic therapy (MT) in DF in a large, homogenous cohort from India.PATIENTS AND METHODSThis study involved histologically confirmed DF cases treated with MT comprising vinblastine (6 mg) and methotrexate (15 mg) both once a week, and tamoxifen (40 mg/m2) in two divided doses once daily between 2002 and 2018.RESULTSThere were 315 patients with a median age of 27 years; the commonest site was extremity (142 of 315; 45.0%). There were 159 (50.1%) male patients. Of the 123 (39.0%) prior treated patients, 119 had surgery. Of 315 patients, 263 (83.5%) received treatment at our institute (MT—151, 77—local treatment, 9—tyrosine kinase inhibitor, and 26 were observed). Among the MT cohort (n = 163, 61.2%), at a median follow-up of 36 (0.5-186) months, the 3-year progression-free and overall survival were 81.1% (95% CI, 74.3 to 88.4) and 99.2% (95% CI, 97.6 to 100), respectively. There were 35% partial responses. Ninety-two patients (56.4%) completed 1-year therapy, which was an independent prognosticator (P < .0001; hazard ratio, 0.177 [95% CI, 0.083 to 0.377]). MT was well tolerated. Predominant grade ≥3 toxicities were febrile neutropenia, 12 (7.4%) without any chemotoxicity-related death. The annual cost of MT was $130 US dollars.CONCLUSIONThe novel, low-cost MT qualifies as one of the effective, less toxic, sustainable, standard-of-care options for the treatment of DF with global reach and merits wide recognition.

Abstract Pancreatic cancer is a highly aggressive malignancy with a poor prognosis owing to its rapid progression, high mortality rate, and alarming 5‐year survival rate of 5%. Skeletal metastases represent an understated site of metastasis in patients with pancreatic cancer, occurring in about 5%–20% of these patients. The clinical presentation of metastasis to the jaws and osteonecrosis of jaw can exhibit similarities, which may lead to an erroneous diagnosis or create a diagnostic dilemma. We present a case of a 62‐year‐old male patient diagnosed with pancreatic adenocarcinoma and a prior history of bisphosphonate administration who displayed symptoms such as jaw pain, numbness, reduced mouth opening, and an extra‐oral swelling involving a recent tooth extraction site, likely due to medication‐related osteonecrosis of the jaw (ONJ). Despite initial conservative treatment, the patient's symptoms persisted, prompting further investigation. Depending on the specific context and clinical scenario, it is crucial to employ a comprehensive approach such as clinical examination, radiographic imaging, histopathological examination and monitoring the progression of symptoms over time for accurate diagnosis and timely management. This article presents a rare case of metastatic pancreatic cancer mimicking medication related ONJ, highlighting the clinical dilemma and challenges encountered when presenting symptoms and signs are ambiguous. While the prognosis for such cases is generally poor, dentists and healthcare providers should remain vigilant regarding potential sites of metastasis in cases of pancreatic adenocarcinoma.

Abstract Anant Ramaswamy Introduction The overall survival (OS) of metastatic colorectal cancers (mCRCs) in clinical practice and resource-constrained low- and middle-income countries (LMICS) like India is not known. Materials and Methods Data of patients with mCRC treated between January 2013 and August 2017 were accessed from a prospectively maintained database. Demographics, disease characteristics, chemotherapeutic regimens, use of monoclonal antibodies, and survival outcomes in treated patients were collected and analyzed. Costs of treatment options as off 2017 were also interpreted. Results The data of 403 patients satisfied prespecified inclusion criteria and were included for analysis. The median age of the cohort was 48 years (range: 17–86) with a predominance of rectal cancers (63.3%), liver alone metastases (47.1%), and resected primary (69.7%). Signet ring histology was present in 82 patients (20.3%). The most commonly used first-line regimen (CT1) was modified capecitabine-oxaliplatin (53.3%). Two hundred and nineteen patients (54.3%) received second-line systemic therapy (CT2). Patients received a median of two lines of therapy (range: 1–6). MoAbs were used by 48 patients (13.4%) with CT1 and 34 patients (15.5%) with CT2. Median OS of the entire cohort was 17.61 months (95% confidence interval: 15.48–19.74), which was within the predicted range, as per investigator hypothesis. The presence of signet ring histology (p

PURPOSEImmune checkpoint inhibitors (ICIs) is the initial line of management in advanced hepatocellular carcinoma (HCC), but survivals in the real world are not known.MATERIALS AND METHODSA retrospective study of patients with advanced HCC receiving ICIs (as first-line therapy or as later lines of therapy) across 11 Indian institutions was conducted. Patients were divided into either cohort 1 (trial-like receiving ICI as first-line therapy), with a Child Pugh score (CTP) of ≤6, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0/1, and no VP4 (main portal vein thrombosis [MPVT]) or cohort 2 (trial unlike) who did not satisfy at least one of the above criteria. The primary end point was 12-month overall survival (OS).RESULTSBetween January 2017 and January 2022, 133 patient data were analyzed. The presence of MPVT was seen in 33 patients (25%). The ICIs used were atezolizumab-bevacizumab, nivolumab, and pembrolizumab in 89 (66%), 44 (33%), and one (1%) patients, respectively. With a median follow-up of 13.8 months, the 12-month OS for the entire cohort was 33.4% (95% CI, 23.6 to 43.2). Patients in cohort 1 (n = 31) had a significantly improved OS compared with patients in cohort 2 (n = 102; 12-month OS, 57.9% [95% CI, 38.5 to 77.3] v 24% [95% CI, 13.4 to 34.6]; P = .005). Patients with CTP A as compared with CTP B (9.7 v 4.3 months; P < .001) and an ECOG PS of 0/1 as compared with a PS of ≥2 (8.7 v 7.2 months; P = .04) and without MPVT (9.4 v 4.0; P < .001) had superior survivals.CONCLUSIONPatients with advanced HCC in the real world, trial-like have survivals in consonance with trial data, whereas patients with features excluding them from trials, such as main portal vein thrombosis, poor ECOG PS, and child Pugh B status, have markedly inferior survivals, despite good tolerance to immunotherapy.

Abstract Omshree Shetty Vikas Ostwal Introduction The present study evaluates the mutation pattern and frequency of BRAF, PIK3CA and RAS in colorectal carcinoma observed in the tertiary cancer center in India. Materials and Methods Consecutive cases of colorectal adenocarcinoma (n = 330) registered from January 2015 to December 2019 (5-year duration) were selected for the study. Molecular analysis for BRAF.PIK3CA (exon 9 and 20) and RAS (KRAS&NRAS) was performed on representative formalin-fixed paraffin-embedded tissues by Sanger sequencing. Results were correlated with clinicopathological features. Patient overall survival (OS) was obtained using Kaplan–Meier method. Results The study cohort was in the age range of 22 to 81 years (median age: 52 years) that included 202 males and 96 females (male: female ratio 2.1:1). BRAF V600E mutation was observed in three cases (1%), while 17 cases (5.7%) had mutations in the PIK3CA gene (exon 9 or exon 20). Mutation analysis for RAS gene (KRAS&NRAS) was observed among 42 (15.4%) cases with KRAS mutation and 11 (4%) cases were positive for NRAS mutations. Among RAS, KRAS G12D was the predominant mutation. Median OS with wild-type RAS was 46.6 months (95% confidence interval [CI]: 22.4–70.8), while for RAS mutated patients, it was 25.6 months (95% CI: 16.7–34.5), hazard ratio: 1.7 (95% CI: 1.1–2.7, p = 0.025). Conclusion This study evaluated the prevalence of BRAF, PIK3CA and RAS mutations in the Indian cohort and its impact on clinical behavior. There was lower incidence of BRAF mutations in this cohort and PIK3CA mutation (single) did not impact survival of the patients.

Abstract Anant Ramaswamy Purpose Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) is a current standard of care for locoregionally advanced gastric adenocarcinomas. There is limited real world data with regard to the tolerance and efficacy of this regimen. Materials and Methods This is a retrospective analysis of gastric cancer patients who were offered neoadjuvant perioperative modified FLOT regimen between December 2016 and October 2018, at the Tata Memorial Hospital, Mumbai. Chemotherapy-related side-effects are reported along with overall survival (OS), as calculated by Kaplan-Meier method. Results Three hundred and forty-three consecutive patients were started on neoadjuvant chemotherapy (NACT) with mFLOT of which 298 patients (87%) completed the planned treatment. A total of 294 patients (86%) underwent curative resection of gastric cancer. Common grade 3 and grade 4 toxicities during NACT were diarrhea in 42 patients (12%) and febrile neutropenia in 27 patients (8%). Toxic death was seen in nine (2.6%) patients. A total of 264 patients (77%) completed planned adjuvant chemotherapy. Common grade 3 and grade 4 toxicities during adjuvant therapy were diarrhea in 42 patients (12%) and febrile neutropenia in 16 patients (6%). With a median follow-up of 19 months, the estimated 2-year median OS was 69.4%. Conclusion Administration of modified FLOT regimen in locoregionally advanced gastric cancers is feasible in clinical practice with high completion rates, though requiring dose modifications due to the incidence of clinically relevant grade 3 to 5 toxicities. Early outcomes with the regimen are on par with survivals from the FLOT-AIO study.

Abstract Prathepa Jagdish Background Hand–foot syndrome (HFS) can result in significant deficits in health-related quality of life (HRQOL) and can lead to poor compliance, dose reduction, or interruption. This study was performed to assess the HRQOL with HFS on physical, psychological, social, and sexual aspects of patients receiving capecitabine-based chemotherapy with gastrointestinal cancer along with validating and assessing the reliability score of the questionnaire. Patients and Methods HFS-related QOL (HF-QOL) questionnaire was developed and validated in a sample of 30 patients randomly selected for this pilot study. The internal consistency of the tool was tested by calculating the Cronbach's α coefficient, while content and construct validity were assessed by Pearson's correlation. Statistical analyses were performed using SPSS version 25.0. Results Out of 30, 22 (73%) patients were males, mean age was 44 ± 13 years; 21 (70%) patients had grade 1 HFS, while 6 (20%) and 3 (10%) patients had grades 2 and 3 HFS, respectively. Cronbach's α coefficient was high for physical (0.79) and sexual scales (0.79), while it was moderately low for psychological (0.65) and social (0.53) domains. The average HF-QOL scores were 70.6 ± 13.2 in physical domain and 71.3 ± 23.7 in sexual domain indicating poor quality of life (QOL), while it was 50.9 ± 9.9 in social domain indicating moderately worse QOL. Grades 2 and 3 of HFS were found to have statistical significance on physical (0.0001), psychological (0.05), and social (0.02) domains, whereas sexual domain did not have any statistical significance (0.594). Conclusion This pilot study showed the feasibility of use and validity of a new patient-reported instrument, the HF-QOL, which measures the effect of HFS on daily activities (physical, psychological, social, and sexual domains) after capecitabine-based chemotherapy.

Abstract Vikas Ostwal Background Ramucirumab is considered a standard of care as second-line therapy (CT2) in advanced gastric cancers (AGCs). The aim of this study was to assess practice patterns and outcomes with ramucirumab among Indian patients with AGCs. Materials and Methods A computerized clinical data entry form was formulated by the coordinating center's (Tata Memorial Hospital) medical oncologists and disseminated through personal contacts at academic conferences as well as via email for anonymized patient data entry. The data was analyzed for clinical characteristics, response rates, and survival outcomes. Results A total of 26 physicians contributed data, resulting in 55 patients receiving ramucirumab and being available for analysis. Median age was 53 years (range: 26–78), 69.1% of patients had greater than two sites of disease, and baseline Eastern Cooperative Oncology Group's performance score (ECOG PS) ≥ 2 was seen in 61.8% of patients. Ramucirumab was used as monotherapy in 10.9% of patients, while the remaining 89.1% received ramucirumab combined with chemotherapy. Median event-free survival (EFS) and median overall survival (OS) with ramucirumab were3.53 months (95% CI: 2.5–4.57) and 5.7 months (95% CI: 2.39–9.0), respectively. Common class specific grade adverse events seen with ramucirumab included gastrointestinal (GI) hemorrhage (9.1% - all grades) and uncontrolled hypertension (Grade 3/4 - 3.6%). Conclusions Ramucirumab appears to have similar efficacy in Indian AGC patients when compared with real-world data from other countries in terms of median EFS, but OS appears inferior due to more patients having borderline ECOG PS and high metastatic disease burden. GI hemorrhages appear more common than published data, although not unequivocally related to ramucirumab.

AIMComplimentary use of Liver directed therapies (LDTs) with systemic chemotherapy has improved oncologic outcomes in colorectal liver metastasis (CRLM). We analysed institutional results of multimodality management.MethodsRetrospective analysis of prospectively maintained database of CRLM patients managed with LDT including surgical resection, Ablation, Transarterial chemoembolization (TACE) or Transarterial radioembolization (TARE) between November 2011 to March 2020. Management plan was decided in multidisciplinary meeting. Resectable tumours underwent surgical resection or ablation or both in some cases. Borderline resectable or unresectable disease was treated with down staging chemotherapy or TACE/TARE followed by resection or ablation. All patients received adjuvant chemotherapy. Factors influencing survival were analysed.ResultsOut of total 375 patients, surgery alone was done in 191 (50.93%) patients while surgery with other LDT in 26 patients (6.93%). Ablation alone was done in 100 (26.66%) whereas TACE/TARE were done as standalone treatment in 21 (5.6%) and 7 (1.86%) patients respectively. TACE + ablation was done in 28 (7.46%) and TARE + ablation was done in 2(0.53%) patients.5-year Overall Survival(OS) was 49.8% while Event free survival(EFS) was 21.4%. The median OS and EFS for surgical group was significantly better than non-surgical group (78 V/s 39 months; p

Purpose The objective of this study was to assess the proportion of patients developing chemotherapy-induced nausea and vomiting (CINV) after receiving chemotherapy for gastrointestinal (GI) cancers, despite receiving antiemetic prophylaxis (AEP) as per the standard guidelines. Patients and Methods Between April 2019 and March 2020, all patients planned for chemotherapy were eligible for enrolment in the study. The primary endpoint of the study was the assessment of complete response (CR) rates. Results Overall, 1,276 consecutive patients were screened for this study, while 738 patients fulfilling the eligibility criteria were included. A total of 23.2% of the whole cohort failed to achieve CR. Also, 28.2, 16.9, and 16.6% of patients receiving moderately emetogenic chemotherapy (MEC), low emetogenic chemotherapy (LEC), and high emetogenic chemotherapy (HEC), respectively, failed to achieve CR. The differences in failure to achieve CR was statistically significant between MEC and HEC (p < 0.001) groups. Among MEC group, there was no difference between those who received oxaliplatin (27.8%) versus nonoxaliplatin regimens (25.8%) in terms of failure rates (p = 0.613). Conclusion Approximately one-fourth of patients failed to achieve a complete response from CINV in GI cancers despite using guideline-based AEP. Patients receiving MEC had the highest failure rates suggesting a need to improve AEP in these patients.

Background Various predictive models have been developed which incorporates patient risk factors into the selection of optimal antiemetic therapy, one of which is chemotherapy-induced nausea and vomiting (CINV) risk scoring system developed by Multinational Association of Supportive Care in Cancer (MASCC). Patients and Methods Consecutive patients with gastrointestinal malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. The CINV risk assessment tool was used to collect the study data and to assess CINV risk score. Results Ninety-eight patients fulfilling the eligibility criteria were included in this study, out of which 57% were males, median age was 48 years (range: 28–77). Colorectal cancer (32.7%) was the most common diagnosis followed by gastric cancer (27.6%). Gemcitabine/cisplatin and CAPOX regimen were the most common regimen being administered in 19.4% each. As per MASCC guidelines, 19.4% patients received highly emetogenic chemotherapy, 69.4% moderately emetogenic chemotherapy, while 11.2% received regimen with low emetogenicity. CINV risk module characterized 52% patients to have high risk for CINV, while 48% to have low risk of CINV, thus, 52% had the discrepancy in risk assigned by two methods, and this was statistically significant (p = 0.025). In subgroup analysis, although patient cohort with acute nausea had no statistically significant discrepancy (p = 0.123), but statistically significant discrepancy was found in patient cohort with delayed nausea (p = 0.001), acute (p = 0.038), and delayed (p < 0.001) vomiting. Conclusion A significant percentage of patients who receive chemotherapy continue to experience nausea and vomiting despite receiving antiemetic treatment as per standard guidelines. The study generates a hypothesis for future large randomized studies looking at change in antiemetic prophylaxis based on CINV risk tool, leading to improvement in complete response rates of acute and delayed CINV.

Background Biliary tract cancers (BTCs) are a rare group of cancers with limited data with respect to advanced unresectable cholangiocarcinoma (CCA). Materials and Methods The study is a retrospective study of patients with advanced unresectable/metastatic CCA, who received first-line palliative chemotherapy (CT1) from January 2014 to March 2019 at the Tata Memorial Hospital, Mumbai. Baseline clinical characteristics, chemotherapeutic regimens, and toxicities were evaluated. Results One hundred and forty patients satisfied criteria for evaluation. Median age of the entire cohort was 57 years (range: 32–80). There were 87 patients (62.1%) with intrahepatic CCA, 35 patients (25%) with perihilar CCA, and 14 patients (10%) with distal CCA. One hundred and twelve patients (80%) had metastatic disease at presentation. Commonest CT1 regimens were gemcitabine–cisplatin (GC) in 89 patients (63.5%) and gemcitabine–oxaliplatin (GO) in 34 patients (24.3%). Sixty-three patients (45%) received second-line chemotherapy. With a median follow-up of 27 months, median progression-free survival for the entire cohort was 7.56 months (95% confidence interval [CI]: 6.23–8.88), and median OS was 12.16 months (95% CI: 10.08–14.24). Common chemotherapy-related grade 3/4 side effects included vomiting in 25 patients (17.9%), diarrhea in 23 patients (16.4%), and thrombocytopenia in 22 patients (15.7%). Conclusion The current study in advanced CCAs is the largest of its nature from India. The common regimens used as first line were GC and GO. Tolerance and overall survival appear similar to previously published data.

Background: Little is known about the comprehensive geriatric assessment (CGA) profile of Indian patients. We aimed to describe the CGA results of the Indian geriatric oncology patients and identify the incidence of polypharmacy. Methods: The study is a retrospective analysis of the data collected in the geriatric oncology clinic at Tata Memorial Hospital, a tertiary cancer hospital in India. Patients aged 60 years and over with malignancy were evaluated. The baseline social, demographic, and disease details were recorded. All patients underwent a CGA, in which the domains of nutrition, function and falls, psychological status, cognition, comorbidities, social support, fatigue, and polypharmacy were evaluated using various validated tools. Life expectancy and the risk of toxicity from chemotherapy were calculated. Based on the results of the CGA, the patients were referred to various specialists and advised methods to address any identified vulnerabilities. The study was approved by the Institutional Review Board, which granted a waiver of the requirement for written informed consent. Results: A total of 251 patients were assessed between June 2018 and March 2020. All patients had solid tumor malignancies, commonly lung (41%) and gastrointestinal (28%). Fifty-nine percent of the patients were planned for palliative intent therapy. The median age was 70 years (range, 60–100). The median number of caregivers was 4 (interquartile range [IQR], 3–6). The median body mass index (BMI) was 21.9 kg/m2 (IQR, 18.9–24.2). The BMI of 109 patients (44%) was < 21 kg/m2. Seventy-eight percent of the patients had comorbidities, commonly hypertension (45%), diabetes (26%), and heart disease (17%). The median number of medications was 5 (IQR, 2–7), and 51% of the patients were on were on 5 or more medications. Only 4 patients (2%) scored normally in all the geriatric domains tested. Abnormalities were noted in the domains of comorbidities (79%), fatigue (77%), nutrition (65%), function and falls (52%), psychological status (32%), and cognition (18%). Seventy percent of the patients had an estimated >51% risk of developing Grade 3 or higher toxicity if treated with full-dose combination chemotherapy. Conclusion: Ninety-eight percent of the Indian geriatric oncology patients had vulnerabilities in at least one geriatric domain. Polypharmacy was noted in more than 50% of the patients. There was an over 50% predicted risk of severe toxicity from combination chemotherapy in at least two out of every three patients.

Background: Data regarding the practice of adjuvant chemotherapy, specifically with modified CAPOX, and survival outcomes in operated colon cancer patients from a nontrial cohort in a lower-middle income and low prevalence nation like India is scarce. Materials and Methods: Patients who underwent upfront curative resection for colon cancer from January 2013 to December 2016 were analyzed for baseline variables and outcomes. Results: A total of 491 patients underwent curative resection in the predefined time period. The median age of the patients was 53 years (range: 17–87). Patients with Stage I, Stage II, and Stage III disease comprised 7.9%, 44.8%, and 45.4% of the entire cohort, respectively. Patients with Stage I cancer were observed. Adjuvant chemotherapy was planned for 384 patients (78.2%), with the doublet regimens (capecitabine-oxaliplatin, or 5-fluorouracil-oxaliplatin) being used commonly (77.6%). Common toxicities were Hand-foot syndrome (Grade 2/3 - 21.4%) and peripheral neuropathy (Grade 2/3 - 20.1%). About 85% of patients receiving monotherapy (capecitabine or 5 fluorouracil) and 81.2% of patients receiving doublet chemotherapy (mCAPOX or modified FOLFOX-7) completed their planned adjuvant treatment. With a median follow-up of 22 months, estimated 3 years event-free survival was 86%, and overall survival (OS) was 93.6%. Stage, younger age (

Background: The optimal use and sequencing of short-course radiotherapy (SCRT) in metastatic rectal cancers (mRCs) are not well established. Materials and Methods: We retrospectively reviewed the records of mRC patients receiving SCRT followed by palliative chemotherapy between January 1, 2013, and December 31, 2016, in Tata Memorial Hospital. Patients were classified as having “potentially resectable” disease (local and metastatic) or “unresectable” disease at baseline based on prespecified criteria. Results: A total of 105 consecutive patients were available for analysis. The median age of patients was 48 years (range: 16–62 years), and 57.1% were male patients. Signet ring histology was seen in 13.3% of patients. The most common site of metastases was liver limited (29.5%), nonloco-regional nodes (12.4%), and lung limited metastases (9.5%). Chemotherapeutic regimens administered were capecitabine-oxaliplatin (70.5%), modified 5 fluorouracil (5 FU)-leucovorin-irinotecan-oxaliplatin (10.5%), and modified 5 FU-leucovorin-irinotecan (8.6%). Targeted therapy accompanying chemotherapy was administered in 27.6% of patients. About 42.1% of patients with potentially resectable disease and 11.1% with the unresectable disease at baseline underwent curative-intent resection of the primary and address of metastatic sites. With a median follow-up 18.2 months, median overall survival (OS) was 15.7 months (95% confidence interval: 10.42–20.99). Patients classified as potentially resectable had a median OS of 32.62 months while patients initially classified as unresectable had a median OS of 13.04 months (P = 0.016). The presence of signet ring morphology predicted for inferior mOS (P = 0.021). Conclusions: SCRT followed by systemic therapy in mRC is a feasible, efficacious paradigm for maximizing palliation, and achieving objective responses. The classification of patients based on resectability was predictive of actual resection rates as well as outcomes. Signet ring mRC show inferior outcomes in this cohort of patients.

Background: Regorafenib is considered a standard of care as third-line therapy in metastatic colorectal cancers (mCRCs). Materials and Methods: The study was based on a computerized clinical data form sent to oncologists across the country for entry of anonymized patient data. The data entry form was conceived and generated by the coordinating center's (Tata Memorial Hospital) gastrointestinal medical oncologists and disseminated through personal contacts at academic conferences as well as through E-mail to various oncologists across India. Results: A total of 19 physicians contributed data resulting in 80 patients receiving regorafenib who were available for the evaluation of practice patterns. The median age was 55 years (range: 24–75). Majority had received oxaliplatin-based (97.5%), irinotecan-based (87.5%), and targeted therapy (65%), previously. Patients were primarily started on reduced doses of regorafenib upfront (160 mg – 28.8%, 120 mg – 58.8%, and 80 mg – 12.5%). The median duration of treatment (treatment duration) with regorafenib was 3.1 months (range: 0.5–18), while the median progression free survival was 3.48 months (range: 2.6–4.3). Forty-five percent of patients required dose modifications due to toxicities, and the most common were (all grades) hand-foot syndrome (68.8%), fatigue (46.3%), mucositis (37.6%), and diarrhea (31.3%). Conclusions: Majority of physicians in this collaborative study from India used a lower dose of regorafenib at the outset in patients with mCRC. Despite a lower dose, there was a significant requirement for dose reduction. Duration of treatment with regorafenib as an efficacy end point in this study is similar to available data from other regions as it is the side effect profile.

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.Exposure(s) Total risk score ranged from 0 (lowest toxicity risk) to 19 (highest toxicity risk).Main outcome(s) and measure(s) 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

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and feared side effects in cancer patients undergoing chemotherapy. Scientific evidence proves its detrimental impact on a patient's quality of life (QoL), treatment compliance, and overall healthcare cost. Despite the CINV-management landscape witnessing a radical shift with the introduction of novel, receptor-targeting antiemetic agents, this side effect remains a chink in the armor of a treating oncologist. Though global guidelines acknowledge patient-specific risk factors and chemotherapeutic agent emetogenic potential in CINV control, a “one-fit-for-all” approach cannot be followed across all geographies. Hence, in a pioneering attempt, India-based oncologists conveyed easily implementable, region-specific, consensus-based statements on CINV prevention and management. These statements resulted from integrating the analysis of scientific evidence and guidelines on CINV by the experts, with their clinical experience. The statements will strengthen decision-making abilities of Indian oncologists/clinicians and help in achieving consistency in CINV prevention and management in the country. Furthermore, this document shall lay the foundation for developing robust Indian guidelines for CINV prevention and control.

Background: Modified 5-fluorouracil/leucovorin/irinotecan (mFOLFIRI) is a commonly used combination second-line chemotherapeutic regimen in advanced gastric cancer (AGC). Materials and Methods: Patients diagnosed with AGC, receiving biweekly mFOLFIRI between July 2013 and June 2016, as second-line chemotherapy were retrospectively analyzed for tolerance, prognostic factors, event-free survival (EFS), and overall survival (OS). Results: Overall, 91 patients were administered a median of 6 cycles of therapy. Response rate was 29.7% and clinical benefit rate was 57.2%. With a median follow-up of 11.5 months, median EFS was 3.98 months (95% confidence interval [CI]: 2.54–5.41) and median OS was 7.73 months (95% CI: 5.30–10.15). Common Grade 3 and Grade 4 adverse events were neutropenia (18.7%), febrile neutropenia (9.9%), thrombocytopenia (7.7%), and vomiting (4.4%). Nearly 33% of patients required dose modification during therapy. Conclusions: mFOLFIRI regimen as a second-line therapy in AGCs appears feasible and efficacious in clinical practice.

Gallbladder cancers (GBC) are common in the Indo-Gangetic belt of India. Most consensus guidelines in the West have considered GBC as part of the biliary tract cancer spectrum; however, considering the markedly higher burden of GBC in India, there is a need to have specific management treatment strategies in the Indian scenario. The extent of surgical resections, the use of staging laparoscopies, the optimum adjuvant therapy for resected high-risk GBC (T3 or T4 disease and node-positive disease), as well as the preferred second-line chemotherapeutic regimens for advanced GBC are questions that remain incompletely defined and answered. The current review presents a synopsis of currently available evidence and emerging approaches in the treatment of GBC.

Aims: The study was carried out to evaluate the early outcomes using Radiofrequency Ablation (RFA) for unresectable liver metastases in the management of metastatic colorectal cancer (mCRC) from an area of low endemicity. Material and Methods: 60 Patients with unresectable colorectal liver metastases had undergone 88 sessions of RFA from January 2007 till December 2013. The results were retrospectively analysed to evaluate the outcomes in terms of efficacy and survival rates. Results: The median follow up of patients in our series was 24.8months. 35/52 (67.3%) patients had complete response at 3 months while 8 patients were lost to follow up. Of the 17 patients who had recurrence, 4 (23.5%) were at the ablated site while 13 patients (76.4%) progressed elsewhere. Abdominal pain was commonest post procedural symptom (20%). There was no procedure related mortality or any major complications. Mean disease free interval and Progression free survival was 6.7 and 13.1 months. Estimated median survival in patients with liver limited disease and those with small lesion (3 cm was associated with decreased survival.

Aim: Data regarding the optimal management of metastatic anorectal melanoma (mARM) is scarce. The primary aim was to evaluate the potential benefits of systemic therapy in mARM. Materials and Methods: This is a retrospective analysis of all mARM who presented between July 2013 and June 2015 at the Department of GI Medical Oncology, Tata Memorial Hospital. Results: Of a total of 37 patients, twelve patients were planned for best supportive care (BSC) only while the remaining 25 patients received systemic therapy. The median overall survival (OS) for the whole cohort was 27 weeks. The OS was significantly better in patients who received first-line therapy as compared to those who were offered BSC (median OS: 14 vs. 33 weeks; P = 0.04). Patients with PS of 1 did significantly better than PS of 2 more (OS 70 vs. 17 weeks; P = 0.015). Conclusion: mARM should be offered chemotherapy, especially in good performance patients. Paclitaxel/Platinum or Capecitabine/Temozolomide regimens can be considered as the preferred regime in the resource-limited setting where immunotherapy may not be a feasible option.

Background: We are a tertiary care cancer center and have approximately 1000–1500 emergency visits by cancer patients undergoing treatment under the adult medical oncology unit each month. However, due to the lack of a systematic audit, we are unable to plan steps toward the improvement in quality of emergency services, and hence the audit was planned. Methods: All emergency visits under the adult medical oncology department in the month of July 2015 were audited. The cause of visit, the demographic details, cancer details, and chemotherapy status were obtained from the electronic medical records. The emergency visits were classified as avoidable or unavoidable. Descriptive statistics were performed. Reasons for avoidable emergency visits were sought. Results: Out of 1199 visits, 1168 visits were classifiable. Six hundred and ninety-six visits were classified as unavoidable (59.6%, 95% CI: 56.7–62.4), 386 visits were classified as probably avoidable visit (33.0%, 95% CI: 30.4–35.8) whereas the remaining 86 (7.4%, 95% CI: 6.0–9.01) were classified as absolutely avoidable. Two hundred and ninety-seven visits happened on weekends (25.6%) and 138 visits converted into an inpatient admission (11.9%). The factors associated with avoidable visits were curative intention of treatment (odds ratio - 2.49), discontinued chemotherapy status (risk ratio [RR] - 8.28), and private category file status (RR – 1.89). Conclusion: A proportion of visits to emergency services can be curtailed. Approximately one-fourth of patients are seen on weekends, and only about one-tenth of patients get admitted.

Background: Primary mutations in the KIT gene are the driving force for gastrointestinal stromal tumors (GIST) tumorigenesis. Predictive role of KIT mutation status aids oncologists in patient management. There is a paucity of comprehensive data on the frequency of mutations in the KIT gene in GIST affecting Indian patients. The aims of this study were to determine the frequency and spectrum of molecular alterations affecting the KIT gene and assess their association with clinicopathologic features in a cohort of patients of GIST. Materials and Methods: Morphological and immunohistochemically confirmed GIST cases (n = 114) accessioned from August 2014-June 2015 were analyzed for mutations in KIT exons 9, 11, 13, and 17 and subjected to Sanger sequencing onto the ABI 3500 Genetic Analyzer. The sequences were analyzed using sequence analysis software: SeqScape® and Chromas Lite. Results: KIT mutations were seen in 70% of cases and the majority of KIT mutations involved exon 11 (57%), followed by exon 9 (10%), exon 13 (3%), and exon 17 (1%). Most common exon 11 mutations were in-frame deletions (61.4%) followed by substitution mutations (19.3%). Exon 9 mutations showed identical duplication of Ala-Tyr at codons 502–503. Simultaneous mutations affecting exon 11 and 13 were discovered. Novel variations, namely, p.Q556E (c.1666C>G), p.Q556dup (c.1666_1668dupCAG), p.K558_V559delinsS (c.1672_1677delAAGGTTinsAGT), p.Y503_F504insTY (c.1509_1510insACCTAT), and p.K642R (c.1925A>G) involving exons 11, 9, and 13, respectively, were observed. Interpretation and Conclusions: First study with complete analysis of all 4 exons of KIT (exons 9, 11, 13, and 17) in Indian GIST patients. Along with well-described KIT mutations, several rare double mutations as well as novel alterations were reported in this series.

Summary: There is paucity of data on the incidence, severity and management of chicken pox in patients receiving active chemotherapy for cancer.From October 2010 to October 2011, patients were included in this study if they developed a chicken pox infection during their chemotherapy. The details of patients’ cancer diagnosis and treatment along with clinical and epidemiological data of the chicken pox infections were assessed from a prospectively maintained database.Twenty-four patients had a chicken pox infection while receiving chemotherapy and/or radiotherapy. The median age of the patients was 21 years, and two-thirds of the patients had solid tumor malignancies.Overall, eight (33%) patients had complications, six (25%) patients had febrile neutropenia, four (17%) had diarrhea/mucositis, and four (17%) had pneumonia. The median time for recovery of the infection and complications in the patients was 9.5 days (5–29 days), whereas for neutropenic patients, it was 6.5 days (3–14 days). The median time for recovery from chicken pox infections in neutropenic patients was 10 days (5–21 days), compared with 8.5 days (0–29 days) in non-neutropenic patients (P = 0.84). The median time for recovery from infections was 8.5 days in patients with comorbidities (N = 4), which was the same for patients with no comorbidities.The clinical presentation and complication rates of chicken pox in cancer patients, who were on active chemotherapy, are similar to the normal population. The recovery from a varicella infection and complications may be delayed in patients with neutropenia. The varicella infection causes a therapy delay in 70% of patients. Aggressive antiviral therapy, supportive care and isolation of the index cases remain the backbone of treatment. Keywords: Chicken pox, Chemotherapy, Solid tumor cancers

Background: The current standard of treatment for advanced hepatocellular cancer Hepatocellular carcinoma (HCC) is Sorafenib. Data regarding its tolerance and adverse event profile in Indian patients is scarce. Materials and Methods: The primary aim of this analysis was to assess the adverse events (Grade 3 and Grade 4 as per CTCAE v4.0) and requirements for dose reduction with sorafenib in advanced HCC. Details of consecutive patients started on 800 mg/day dosing were obtained from a prospectively maintained database (over a period of 6 months) and analyzed. Results: Thirty-nine patients were available for inclusion in the study. Median age was 58 years (range: 20–75). All patients were classified as Barcelona clinic liver cancer C. Common side effects seen were liver dysfunction (38.5%), hand-foot-syndrome-rash (HFSR) (Grade 2 and 3-25.6%), fatigue (Grade 2 and Grade 3–10.3%), and diarrhea (7.7%). Dose reduction was required in 43.6% of patients. Drug interruptions/cessation was required in 38.5% of patients within the first four months of treatment. Nearly 41% of patients required cessation of sorafenib due to intolerable side-effects while 28.2% stopped sorafenib due to progressive disease. At a median follow-up of 4.9 months, median event-free survival (EFS) was 4.20 months (95% confidence interval: 3.343–5.068). Conclusion: A higher incidence of liver dysfunction and HFSR is seen in Indian patients as compared to published data. A significant proportion of patients required cessation of sorafenib due to adverse events in our series. However, EFS remains on par with that seen in larger studies with sorafenib in advanced HCC.

Background: Management of advanced Gastrointestinal stromal tumors (GIST) has been revolutionized with the use of Imatinib guided by mutation analysis. Data from India remains scarce. Materials and Methods: Patients with metastatic GIST who were treated at Department of Gastro-intestinal & Hepaticopancreaticobiliary Oncology Unit at Tata Memorial Hospital, Mumbai between December, 2004 and December 2015 were included in the analysis. Clinical and radiological data was retrieved from stored medical records and charts. Results: A total of 83 patients with metastatic GIST were available for analysis. Median age was 54 years with a 3:1 male predominance. Stomach was the most common site of primary with liver being the most common site of metastasis. c-Kit mutation analysis results were available for 44 patients with exon 11 mutant being the most common mutation. With a median follow up of 33 months, the 10 years estimated progression free and overall survival (OS) was 18% and 51% respectively. Overall response rate to first line imatinib was 37.6% and estimated 3 years OS to first line therapy was significantly better for Exon 11 mutated patients (p=0.016). 34 patients received second line therapy in the form of either sunitinib, pazopanib or increased dose imatinib with a clinical benefit rate of 73.5%. C-Kit mutated patients had a better median OS compared to non mutated patients. Conclusions: GIST diagnosed and treated in the Indian subcontinent appears to show improved outcomes. The importance of c-Kit mutation analysis in determining the prognosis and outcomes of patients with advanced GIST is emphasized.

Introduction: Staging laparoscopy (SL) is the current standard staging workup for loco-advanced gastric cancers (GCs). Materials and Methods: We analyzed the data of all patients with loco-regionally advanced, nonmetastatic GCs, who underwent SL for the evaluation of peritoneal carcinomatosis (PC). Results: Between December 2013 and October 2016, 363 patients underwent SL, of which 75 (20.7%) were found to have PC on SL. Age ≤40 years, CA 19-9 > upper limit of normal, and low serum albumin levels (≤3.5 g/dl) correlated significantly with the presence of PC on SL. There was a statistically significant difference in the median overall survival between patients with radiologically detected PC and SL detected PC (8.67 months vs. 15.3 months;P < 0.0001).Conclusion: SL upstaged disease status in 20.7% of patients. Clinical factors, identified in this study, need further validation in larger prospective cohorts before being used in clinical practice. Patients with radiologically detected PC have lower survival as compared to those with PC on SL.

Aim: To study the efficacy and safety of paclitaxel and platinum doublet chemotherapy in penile cancer patients with high-risk features of local failure. Materials and Methods : Retrospective analysis was done of patients with 19 carcinoma of the penis who were offered adjuvant chemotherapy with paclitaxel and platinum combination. The data regarding the surgical details, high-risk features for which chemotherapy was offered, chemotherapy toxicity details (in accordance with CTCAE vs 3), failure pattern, and survival data were noted. SPSS version 16 was used for statistical analysis. Descriptive and Kaplan-Meier survival analysis was performed. Results : Median age of patients was 48 years. Fifteen patients received paclitaxel in combination with cisplatin and four received paclitaxel with carboplatin in view of their low serum creatinine clearance. The treatment was completed by 12 patients (63.2%). Of 79 planned cycles, 50 were taken. The treatment was well tolerated with grade 3-4 gastrointestinal toxicity was seen in 1 patient, grade 3 neurological toxicity in one and grade 5 neutropenia in one patient. Treatment related death occured in one patient. The median follow-up was 15.33 months and 6 loco-regional relapsed had taken place. The estimated median DFS was 16.2 months and the estimated median OS was not reached. The estimated DFS for treatment completed patients was 23.13 months as against 2.16 months for patients not completing treatment. Conclusion: The platinum and taxane doublet chemotherapy was found to be safe and effective.