Adjuvant Gemcitabine Plus Cisplatin and Chemoradiation in Patients With Gallbladder Cancer: A Randomized Clinical Trial.

Importance: There is limited evidence with regard to the benefit of adjuvant chemotherapy chemoradiotherapy in resected gallbladder cancers (GBCs). Objective: To establish a baseline survival rate for operated GBCs in patients receiving either gemcitabine plus cisplatin (GC) or capecitabine and capecitabine concurrent with chemoradiation (CCRT). Design, Setting, and Participants: The GECCOR-GB study was a multicenter, open-label, randomized phase 2 noncomparator "pick the winner" design trial of adjuvant GC and CCRT in patients with resected histologically confirmed adenocarcinoma or adenosquamous carcinoma of the gallbladder, (stage II/III) with no local residual tumor (R0) or microscopic residual tumor (R1). The study was carried out in 3 tertiary cancer institutions in India. Patients 18 years or older with adequate end-organ functions, and Eastern Cooperative Oncology Group Performance Status of 1 or lower between May 2019 and February 2022 were enrolled. The cutoff date for data analysis was February 28, 2023. Interventions: Patients were randomized 1:1 to receive either GC every 3 weeks (maximum of 6 cycles) or CCRT comprising capecitabine with concurrent chemoradiation (capecitabine concurrent with radiotherapy) sandwiched between capecitabine chemotherapy. Main Outcomes and Measures: The primary outcome was disease-free survival (DFS) at 1 year in randomized patients. This study was conducted as 2 parallel, single-stage phase 2 clinical trials. Within each treatment arm, a 1-year DFS rate of less than 59% was considered as insufficient activity, whereas a 1-year DFS rate of 77% or higher would be considered as sufficient activity. Results: With a median follow-up of 23 months, 90 patients were randomized, 45 in each arm. Overall, there were 31 women (69%) and 14 men (31%) in the GC arm with a mean (range) age of 56 (33-72) years and 34 women (76%) and 11 men (24%) in the CCRT group with a mean (range) age of 55 (26-69) years. In the GC and CCRT arms, 1-year DFS and estimated 2-year DFS was 88.9% (95% CI, 79.5-98.3) and 74.8% (95% CI, 60.4-89.2), and 77.8% (95% CI, 65.4-90.2) and 74.8% (95% CI, 59.9-86.3), respectively. Completion rates for planned treatment was 82% in the GC arm and 62% in the CCRT arm. Conclusions and Relevance: In this randomized clinical trial, GC and CCRT crossed the prespecified trial end points of 1-year DFS in patients with resected stage II/III GBCs. The results set a baseline for a larger phase 3 trial evaluating both regimens in operated GBCs. Trial Registration: ClinicalTrials.gov Identifier: CTRI/2019/05/019323I.

Outcome of early detection approach in control of breast, cervical, and oral cancer: Experience from a rural cancer center in India.

In low- and middle-income countries most of the cancer patients attend the hospital at a late stage and treatment completion of these cases is challenging. The early detection program (EDP), in rural areas of Punjab state, India was initiated to identify breast, cervical, and oral cancer at an early stage by raising awareness and providing easy access to diagnosis and treatment. A total of 361 health education programs and 99 early detection clinics were organized. The symptomatic and self-interested (non-symptomatic individuals who opted for screening) cases visited the detection clinic. They were screened for breast, cervical, and/or oral cancer. Further diagnosis and treatment of screen-positive cases were carried out at Homi Bhabha Cancer Hospital (HBCH), Sangrur. Community leaders and healthcare workers were involved in all the activities. The EDP, Sangrur removed barriers between cancer diagnosis and treatment with the help of project staff. From 2019 to 2023, a total of 221,317 populations were covered. Symptomatic and self-interested individuals attended the breast (1627), cervical (1601), and oral (1111) examinations. 46 breast (in situ-4.3%; localized-52.2%), 9 cervical (localized-77.8%), and 12 oral (localized-66.7%) cancer cases were detected, and treatment completion was 82.6%, 77.8%, and 50.0%, respectively. We compared cancer staging and treatment completion of cases detected through EDP with the cases attended HBCH from Sangrur district in 2018; the difference between two groups is statistically significant. Due to the early detection approach, there is disease down-staging and improvement in treatment completion. This approach is feasible and can be implemented to control these cancers in low- and middle-income countries.

Nonlinear Optical Properties of Discotic Hexylthiotruxene Derivatives.

The search for efficient and transparent nonlinear optical (NLO) media has led to the investigation and development of alternative organic optical materials. In this context, a series of new hexylthiotruxene derivatives have been synthesized, and their linear and NLO properties are explored. These truxene derivatives show large NLO absorption due to their C3 symmetry, presence of large hyperpolarizability, and extended π-conjugation. Herein, we show that two-photon absorption and three-photon absorption processes are the main cause of nonlinear absorption in these materials under 5 ns and 100 fs excitations at 532 and 800 nm excitations, respectively. The nonlinear absorption coefficients have high values of 2 to 7.9 × 10-10 m/W in the nanosecond domain and 2.2 to 7.4 × 10-21 m3/W2 in the femtosecond domain. The corresponding nonlinear absorption cross-section (δ) values and the nonlinear susceptibilities were also calculated from the numerically obtained nonlinear absorption coefficient values. Tailored truxene derivative showed an excellent optical limiting threshold of 4.5 J/cm2 and is comparable to or better than most recently reported and benchmark optical limiting materials. Longer alkyl members of the series showed the largest nonlinear absorption in both excitation domains and could be a potential optical limiter.

A Clinicopathological Analysis of Molecular Subtypes of Breast Cancer using Immunohistochemical Surrogates: A 6-Year Institutional Experience from a Tertiary Cancer Center in North India.

Puneet Kaur SomalObjective Classification of breast cancer into different molecular subtypes has important prognostic and therapeutic implications. The immunohistochemistry surrogate classification has been advocated for this purpose. The primary objective of the present study was to assess the prevalence of the different molecular subtypes of invasive breast carcinoma and study the clinicopathological parameters in a tertiary care cancer center in rural North India. Materials and Methods All female patients diagnosed with invasive breast cancer and registered between January 1, 2015, and December 31, 2020, were included. Patients with bilateral cancer, missing information on HER2/ER/PR receptor status, absence of reflex FISH testing after an equivocal score on Her 2 IHC were excluded. The tumors were classified into different molecular subtypes based on IHC expression as follows-luminal A-like (ER- and PR-positive, Her2-negative, Ki67 < 20%), luminal B-like Her2-negative (ER-positive, Her2-negative and any one of the following Ki67% ≥ 20% or PR-negative/low, luminal B-like Her2-positive (ER- and HER2-positive, any Ki67, any PR), Her2-positive (ER- and PR-negative, Her2-positive) and TNBC (ER, PR, Her2-negative). Chi square test was used to compare the clinicopathological parameters between these subtypes. Results A total of 1,625 cases were included. Luminal B-like subtype was the most common (41.72%). The proportion of each subtype was luminal A (15.69%), luminal B Her2-negative (23.93%), luminal B Her2-positive (17.78%), Her2-positive (15.26%), TNBC (27.32%). Majority of the tumors were Grade 3 (75.81%). Nodal metastases were present in 59%. On subanalysis of the luminal type tumors without Her2 expression (luminal A-like and luminal B-like (Her2-negative), luminal A-like tumors presented significantly with a lower grade ( p < 0.001) and more frequent node-negative disease in comparison to luminal B-like (Her2-negative) tumors. In comparison to other subtypes, TNBC tumors were more frequently seen in the premenopausal age group ( p < 0.001) and presented with node-negative disease ( p < 0.001). Conclusion This is one of the largest studies that enumerates the prevalence of various molecular subtypes of breast cancer in North India. Luminal B-like tumors were the most common followed by TNBC. TNBC tumors presented more commonly in premenopausal age group and with node negative disease in comparison to other subtypes.

Deciphering the Patterns of Dual Primary Cases Registered at the Hospital-Based Cancer Registry: First Experience from Rural Cancer Center in North India.

Objectives The objective is to present the patterns of dual primary malignancies diagnosed at the Pathology Laboratory of Cancer Hospital with the support from hospital-based cancer registry (HBCR), Sangrur, Punjab, India for the years 2018 and 2019. Methods HBCR abstracts data from electronic medical records. Trained cancer registry staff abstracts cases in standard pro forma. Dual primary was coded as per the International Agency for Research on Cancer rule and was rechecked by the pathologist. Statistical Analysis Data about multiple primary was entered and documented in an Excel sheet. Time interval was calculated by subtracting the date of diagnosis for second primary and first primary. Results A total of 6,933 cases were registered, 45 cases are dual primary (26 females, 19 males) of which 64.4% are synchronous and 35.6% metachronous cases. Seventy-nine percent received cancer-directed treatment for synchronous and 87% for metachronous. The most common sites of the primary tumor were breast (33%), head and neck (22.2%), gynecological sites (11%), prostate (9%), esophagus (4%), and remaining other tumors (20.8%). Most common sites for second malignancies were gastrointestinal (GI) tract (31%), gynecological sites (18%), head and neck (16%), hematological malignancies (7%), soft tissue sarcoma (4%), breast (2%), and other sites (22%). Conclusion More than 70% of cases of primary tumors were in breast, head and neck, gynecological, and prostate. Of these, more than 60% of the second malignancy was found in the GI tract, gynecological, and head and neck sites. Around two-thirds of dual tumors are synchronous. Breast cancer cases have higher incidence of second malignancy. Regular follow-up is necessary to assess the survival of the second primary.

Overall survival of prostate cancer from Sangrur and Mansa cancer registries of Punjab state, India.

Introduction: There is a scarcity of population-based prostate cancer survival data in India. We assessed the population-based, overall survival of patients with prostate cancer from the Sangrur and Mansa cancer registries of the Punjab state, India. Methods: In the year 2013-2016, a total of 171 prostate cancer cases were registered in these two registries. Based on these registries, survival analysis was performed using the date of diagnosis as the starting date and the last follow-up date being December 31, 2021 or the date of death. Survival was calculated using STATA software. Relative survival was calculated using the Pohar Perme method. Results: Follow up was available for all the registered cases. Of the 171 cases, 41 (24%) were alive and 130 (76.0%) were dead. Of the prescribed treatments, 106 (62.7%) cases completed the treatment and 63 (37.3%) cases did not complete the treatment. Overall, 5-year age-standardized prostate cancer relative survival was 30.3%. Patients who completed the treatment had a 7.8 times higher 5-year relative survival (45.5%) compared to those who did not (5.8%). The difference between the two groups is statistically significant (hazard ratio 0.16, 95% confidence interval [0.10-0.27]). Conclusion: To improve survival, we need to raise awareness in the community and among primary physicians so that prostate cancer cases can reach the hospital early and should be treated effectively. The cancer center should develop the systems in their hospital so that there will be no hurdles to the patients in treatment completion. We found a low overall relative survival among patients of prostate cancer in these two registries. Patients who received treatment had a significantly higher survival.

Early endometrial carcinoma: Experience and outcomes.

Aim: Endometrial carcinoma (EC) data from India are very sparse. We did a retrospective analysis of our patients registered at this peripheral cancer center based in rural Punjab and studied their outcome. Materials and Methods: Ninety-eight Stage I and II EC patients with endometroid histology registered at our institute from January 2015 to April 2020 were studied for demography, histopathology, treatment received, and outcomes. FIGO 2009 staging and new European Society for Medical Oncology (ESMO) risk group classification was used. Results: Our patients had a median age of 60 years (range 32-93 years). There were 39 (39.8%), 41 (42.0%), 4 (4.1%), 12 (12.2%) patients in the low risk, intermediate risk (IR), high intermediate risk, and high risk groups, respectively, as per new ESMO risk classification. Two (2.0%) patients had incomplete information to assign them to a particular risk group. Fifty (46.7%) patients underwent complete surgical staging and 54 (50.5%) patients received adjuvant RT. With a median follow-up of 27.0 months, there were 1 locoregional and 2 distant recurrences. There were 8 deaths in total. Three-year overall survival for the entire group is 90.6%. Conclusions: The risk group determines adjuvant treatment in endometrial cancer. Patients operated at dedicated cancer center tend to have better surgical staging and thus better outcome because of better risk stratification and grouping for adjuvant therapy. IR histology was more common in our group of patients, which is variable as compared to available literature.

Challenges Encountered and Pattern-Based Analysis of Bone Marrow Biopsy in Lymphomas: An Institutional Experience.

Objective The evaluation of bone marrow (BM) status is an integral part of the initial workup of patients diagnosed with lymphoma as it plays an important role in staging and predicting prognosis in these patients. This article determines the incidence and pattern of BM involvement in lymphoma cases and distinguishes benign from malignant lymphoid aggregates in BM biopsies. Materials and Methods The study group included 121 cases of Hodgkin and non-Hodgkin lymphomas for which BM biopsies were performed, fixed in acetic acid-zinc formalin solution, decalcified using 10% formic acid, and subjected to hematoxylin and eosin and immunohistochemistry. Results The overall incidence of BM biopsy involvement in our study was 31.4% (37/118), including 34.7% (35/101) in cases of B cell lymphomas, 25% (2/8) in cases of T cell lymphomas, and no involvement in Hodgkin lymphoma. The predominant histological pattern of BM involvement was diffused (14/37; 37.8%), followed by interstitial (10/37; 27.1%). Five cases revealed benign nonparatrabecular lymphoid aggregates which could be confused with lymphomatous involvement, especially in low grade lymphomas. Conclusion A careful examination of the BM biopsies along with clinical history, peripheral blood examination, flow cytometry, and immunohistochemistry will help in arriving at the correct diagnosis.

Recurrence pattern with respect to two different dose fractionations in patients with locally advanced head and neck cancer treated with chemoradiation using image-guided volumetric arc therapy.

BACKGROUND: Patients with head and neck cancer were treated with either 70 Gy in 35 fractions (Arm A) or 66 Gy in 30 fractions (Arm B). MATERIALS AND METHODS: Total 168 patients of carcinoma oropharynx, larynx, and hypopharynx treated with radical chemoradiation in two Arm A versus B (65 vs. 103 patients). RESULTS: With a median follow-up of 16 months (0-67), 2 year disease-free survival (DFS) and overall survival (OS) was 56.3% versus 62.1% (p = 0.64) and 44.5% versus 53.0% (p = 0.51) in Arm A versus B. Total 22 (33.8%) versus 28 (27.2%) failed locoregionally. Majority of failures were infield for both primary (17 vs. 23 cases) and nodes (13 vs. 12) in Arm A versus B. Ten (71.4%) vs. 10 (76.9%) had nodal failure in index nodal level only. CONCLUSION: Commonly seen failure in head-neck radical chemoradiation is within infield high-risk volume, nodal failure being most common in index nodal level.

Adequacy of Histopathology Reports Representing Oncologic Resection Specimens: An Experience of Reporting Practice in Rural India.

CONTEXT.­: The histopathology reporting practice in rural areas is largely variable. To ensure the adequacy of histopathology reports (HPRs), the College of American Pathologists (CAP) has developed cancer reporting checklists. OBJECTIVE.­: To assess the adequacy of resection specimen HPRs received from outside centers for a second opinion. Further, the adequacy of breast resection HPRs from these centers was compared with that of our center. Additionally, the reports representing endometrial carcinoma were assessed for impact on the treatment decision. DESIGN.­: This was a retrospective study conducted from June 2015 to December 2019. HPRs from outside centers and our institute were analyzed for mandatory reporting elements as per CAP 2013 checklists. RESULTS.­: A total of 730 HPRs (558 outside HPRs and 172 in-house breast HPRs) were reviewed for completeness. The outside HPRs were complete in 42 of 558 cases (7.5%). Only 11 of 143 reports (7.7%) from the academic centers were complete. Seventeen of 249 outside breast HPRs (6.8%) were complete, whereas predominant (n = 123 of 172; 71.5%) in-house breast HPRs were adequate. Most outside endometrial carcinoma reports (60.8%; n = 28 of 46) were inadequate with potential impact on the adjuvant treatment, whereas 10 of 46 reports (21.7%) were inadequate and had an actual impact on the adjuvant treatment decision. CONCLUSIONS.­: Minimal data set reporting using checklists is not yet widely operational in most rural laboratories. We call for continuous education and sensitization of the practicing pathologists, oncopathology education of the trainees, and regulatory standards for signing out an oncopathology report.

Rootstocks Overexpressing StNPR1 and StDREB1 Improve Osmotic Stress Tolerance of Wild-Type Scion in Transgrafted Tobacco Plants.

In grafted plants, the movement of long-distance signals from rootstocks can modulate the development and function of the scion. To understand the mechanisms by which tolerant rootstocks improve scion responses to osmotic stress (OS) conditions, mRNA transport of osmotic responsive genes (ORGs) was evaluated in a tomato/potato heterograft system. In this system, Solanum tuberosum was used as a rootstock and Solanum lycopersicum as a scion. We detected changes in the gene expression levels of 13 out of the 21 ORGs tested in the osmotically stressed plants; of these, only NPR1 transcripts were transported across the graft union under both normal and OS conditions. Importantly, OS increased the abundance of StNPR1 transcripts in the tomato scion. To examine mRNA mobility in transgrafted plants, StNPR1 and StDREB1 genes representing the mobile and non-mobile transcripts, respectively, were overexpressed in tobacco (Nicotiana tabacum). The evaluation of transgenic tobacco plants indicated that overexpression of these genes enhanced the growth and improved the physiological status of transgenic plants growing under OS conditions induced by NaCl, mannitol and polyethylene glycol (PEG). We also found that transgenic tobacco rootstocks increased the OS tolerance of the WT-scion. Indeed, WT scions on transgenic rootstocks had higher ORGs transcript levels than their counterparts on non-transgenic rootstocks. However, neither StNPR1 nor StDREB1 transcripts were transported from the transgenic rootstock to the wild-type (WT) tobacco scion, suggesting that other long-distance signals downstream these transgenes could have moved across the graft union leading to OS tolerance. Overall, our results signify the importance of StNPR1 and StDREB1 as two anticipated candidates for the development of stress-resilient crops through transgrafting technology.

Presentation and Spectrum of Male Breast Cancer in a Rural Cancer Center in a Subunit of Tata Memorial Center, India.

This is a retrospective study of the incidence and clinical profile of male breast cancer (MBC) presenting to a rural cancer center in Punjab, India. All MBC cases registered over a period of 4.5 years from January 2015 to July 2019 were included. The study included 34 MBC patients accounting for 1.9% of all breast cancer cases with median age of 62.5 years. All patients were from Punjab except one, with majority from district Sangrur. Family history was present in 7 (20.6%) patients. Mean BMI (n = 23) was 24.8. The median duration of symptoms was 6 months (range 1-60 months). Main complaint was lump in 58.8% of patients followed by lump with ulceration (41.2%). All cases were mostly unilateral, left in 21 (61.8%) and right in 13 (38.2%), and one had bilateral breast cancer. Most tumors were centrally located (70.6%). Infiltrating ductal carcinoma and grade 3 were the commonest histology. ER positivity was high seen in 76.5% cases. In our study, 16 (47.1%) patients presented with distant metastasis at the time of diagnosis, and 10 (39.1%) were locally advance. Bone (41%) followed by lung (17%) were the most common sites of metastasis. Thirteen patients were treated radically, nine were treated with palliative intent, and twelve patients defaulted. Median follow-up period was 16.5 months. MBC constituted 1.9% of all breast cancers registered at our institute, which is higher than worldwide average. Our study population had a longer time to presentation, and majority were metastatic.

Determinants of completion of cancer directed treatment: an experience from a rural cancer centre, Sangrur, Punjab state, India.

In low and middle-income countries, access to cancer diagnosis and treatment is suboptimal. Further, compliance to cancer treatment is a major issue due to various reasons including financial barriers, lack of family support and fear of treatment. This article discusses the determinants of treatment completion in cancer patients of a government-run hospital, in a rural part of Punjab in India. The Sangrur hospital-based cancer registry data for the year 2018 have been used. We have registered 2,969 cancer cases, out of which 2,528 (85%) cases were eligible for the analysis. Of the total 2,528 cases, 1,362 (54%) cases completed the cancer directed treatment and 1,166 (46%) did not. The data have been collected from the electronic medical record (EMR) department and entered into CanReg5 software. The bivariate and multivariate binary logistic regression analysis was performed to see the effect of variables on the treatment completion. The results indicate that the elderly age group (>60 years) (odds ratio (OR): 0.52, (95% confidence interval (CI): 0.31-0.86)), distance from hospital (OR: 0.67, (95% CI: 0.50-0.89)) and access to government health schemes (OR: 0.13, (95% CI: 0.10-0.19)] have direct correlation with the treatment completion. The educated patients (OR: 1.49, (95% CI: 1.13-1.96)) and patients who received curative treatment (OR: 2.7, (95% CI: 1.88-3.88)) have shown 58% and 84% compliance to treatment completion, respectively. The other variables like the clinical extent of disease, religion, gender and income do not have any significant effect on the treatment completion. Determinants like age (young), education, distance from the hospital, curative treatment and availability of government health schemes for financial support have shown positive effects on treatment completion. These factors have to be considered by the cancer hospitals, health departments and policymakers while planning for cancer care or control in India.

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.

BACKGROUND: Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings. METHODS: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed. RESULTS: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01). CONCLUSIONS: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.

Efficacy of gefitinib in epidermal growth factor receptor-activating mutation-positive nonsmall cell lung cancer: Does exon 19 deletion differ from exon 21 mutation?

BACKGROUND: This study was designed to evaluate the differential effect of epidermal growth factor receptor (EGFR) mutation status (exon 19 vs. 21) on progression-free survival (PFS) and overall survival (OS) in treatment-naïve advanced EGFR mutation-positive nonsmall cell lung cancer (NSCLC) treated with gefitinib as first-line agent. METHODS: This was a post hoc analysis of EGFR-mutated (exon 19 and 21) advanced-stage (Stage IIIB or IV), chemotherapy-naive NSCLC patients treated with gefitinib as first line in a phase 3 randomized study. Patients were treated with gefitinib 250 mg daily. Patients underwent axial imaging for response assessment on D42, D84, D126, and subsequently every 2 months till progression. Responding or stable patients were treated until progression or unacceptable toxicity. SPSS was used for statistical analysis. Kaplan-Meier method was used for survival estimation and log-rank test for comparison. Cox proportion hazard model was used for multivariate analysis. RESULTS: One hundred and forty-one patients were eligible for analysis, of which 78 were males and 63 were females. A total of 127 patients (90.1%) were ECOG 0-1 while 14 patients (9.1%) were ECOG >1. Exon 21 mutation was present in 65 patients (46.1%) and exon 19 mutation in 76 patients (53.9%). One hundred and thirty-three of 141 patients were evaluable for response. Response rate of patients having exon 19 mutation was 72.9% (51 patients, n = 70) while it was 55.6% in patients having exon 21 mutation (35 patients, n = 63) (P = 0.046). Median PFS in exon 19-mutated patients was 9.3 months (95% confidence interval [CI] 6.832-11.768) compared to 7.8 months (95% CI 5.543-10.0) (P = 0.699) in exon 21-mutated patients. The median OS in exon 19-mutated patients was 19.8 months (95% CI 16.8-22.7), and it was 16.5 months (95% CI 10.9-22.1) in exon 21-mutated patients (P = 0.215). CONCLUSION: There were no differential outcomes in the Indian patients of advanced-stage NSCLC with exon 19 and 21 EGFR mutations treated with gefitinib.

Treatment practices for metastatic pancreatic cancer: Can we deliver an appropriately efficacious and safe regimen in Indian patients?

INTRODUCTION: The median overall survival (mOS) in metastatic pancreatic cancers (PCs) hovers between 6 months to 11 months. MATERIALS AND METHODS: The study is a retrospective analysis of metastatic PC patients who were evaluated from August 2013 to August 2016 in the Department of Gastrointestinal (GI) Medical Oncology, Tata Memorial Hospital (TMH). RESULTS: Out of 218 patients, 24 patients (11%) were not planned for chemotherapy and referred to the Department of Palliative Care for further supportive care. One hundred and fifty-three patients received palliative chemotherapy in TMH with median age of 56 years (range: 23-79), male (60.1%), and nonresident in Maharashtra (60.1%). Regimens used most commonly were gemcitabine-nab-paclitaxel in 60 patients (39.2%), gemcitabine-erlotinib in 25 patients (16.3%), and modified FOLFIRINOX in 21 patients (13.7%). A total of 58 patients (43%; n = 135) had Grade 3/4 toxicities. As of cutoff date for the analysis of outcomes, 139 patients (90.8%) patients had ceased first-line chemotherapy, due to radiologically proven progressive disease (PD) in 89 patients (64%), repeated Grades 3 and 4 adverse events in 26 patients (18.7%), and clinically PD in 18 patients (12.9%). With a median follow-up of 278 days, the mOS was 217 days (95% confidence interval [CI]: 175-258), and the median event-free survival was 125 days (95% CI: 107-122). CONCLUSION: Dose modifications for chemotherapy are required commonly when treating metastatic PC, with common reasons for dose reduction being toxicities, Eastern Cooperative Oncology Group performance status >=2, and low albumin levels. Studies evaluating logistic and financial aspects of treating metastatic PC with chemotherapy in India are warranted.

Outcomes with second-line chemotherapy in advanced pancreatic cancers: A retrospective study from a tertiary cancer center in India.

INTRODUCTION: Approximately 40% of patients receiving first-line chemotherapy (CT1) for advanced pancreatic adenocarcinomas (PDACs) receive second-line chemotherapy (CT2). The most appropriate regimen to be used has not been identified, and data regarding CT2 in advanced PDAC from India are scarce. MATERIALS AND METHODS: A retrospective analysis of advanced PDAC patients who were evaluated during the period of August 2013 to August 2016 in the Department of GI medical Oncology, at Tata Memorial Hospital was conducted. Patients with histologically proven PDAC and started on CT2 postprogression or recurrence after CT1 were included for analysis. RESULTS: A total of 237 patients received CT1 in the period of study, of which 76 patients (39.66%) received CT2. The median age of patients was 59.5 years (range: 38-82), majority were male (69.7%), and 14 patients (18.4%) had undergone curative pancreatic resection at baseline. The common regimens used as CT2 were modified 5 fluorouracil/leucovorin/irinotecan (mFOLFIRI) (35.5%), gemcitabine-nab paclitaxel (18.4%), and gemcitabine-erlotinib (11.8%). Common grade 3/4 toxicities noted were fatigue (10.3%), anemia (10.3%), neutropenia (7.4%), and vomiting (7.4%). Dose reductions were required in 32.9% of patients. RR, DCR, median event free survival, and median overall survival were 21.1%, 48.7%, and 5.94 months (95% confidence intervals [CI]: 4.68-7.20) and 8.08 months (95% CI: 7.11-9.07) respectively. CONCLUSIONS: CT2 in advanced PDAC appears feasible in the Indian setting if the patients are appropriately selected and they can be treated with acceptable toxicities and reasonable outcomes.

Efficacy of Second-Line Pemetrexed-Carboplatin in EGFR-Activating Mutation-Positive NSCLC: Does Exon 19 Deletion Differ from Exon 21 Mutation?

BACKGROUND: It is unknown whether the outcomes of second-line pemetrexed-carboplatin chemotherapy administered after progression on gefitinib are dependent on type of EGFR mutation present at baseline. METHOD: Adult non-small-cell lung cancer patients, with exon 19 deletion or exon 21 L858R mutation, who progressed on gefitinib and received pemetrexed-carboplatin chemotherapy were selected for this analysis. RESULT: 55 patients received pemetrexed-carboplatin as second-line treatment. Response rates in evaluable patients were 39.3% in exon 19 patients (n = 28) and 33.3% in exon 21 patients (n = 15) (p = 0.752, Fisher's exact 2-sided p value). The median PFS in exon 19 and 21 cohorts was 5.900 months (95% CI: 4.274-7.526) and 4.767 months (95% CI: 1.374-8.159), respectively. The median overall survival in exon 19 patients was (11.8 months, 95% CI: 9.916-13.684 months) significantly better than that seen in exon 21 mutation patients (6.2 months, 95% CI: 4.215-8.118 months, p = 0.024) on univariate analysis; however, on multivariate analysis, this association was not confirmed (HR = 0.361, 95% CI: 0.090-1.439, p = 0.149). CONCLUSION: Exon 19 deletion has no impact on PFS and OS in EGFR-mutated patients treated with second-line pemetrexed-carboplatin.