Demographic and clinical profile of 1106 adult soft tissue sarcoma patients: A single institutional prospective database experience from India.

BACKGROUND: Adult soft tissue sarcomas (STS) are rare and diverse. Current management is based on limited literature from the West. Therefore, data from different geographical regions is required, including the low-middle-income countries. This is our experience managing adult sarcomas in the tertiary cancer center of North India. MATERIALS AND METHODS: This is a retrospective analysis of the structured sarcoma database of patients treated in the surgical oncology department between 1992 and 2020. The descriptive analysis includes demography, site distribution, diagnosis, histopathology variations, prior surgical interventions, and stage. RESULTS: A total of 1106 soft tissue sarcoma patients were treated in three decades. Age distribution was 13%, 43%, 31%, and 11% in <20, 21-40, and 41-60 and >60 years, respectively. The male-to-female ratio was 1.73. The anatomical distribution was 17%, 42%, 23%, 7%, 7%, and 3% in upper extremity, lower extremity, trunk, retroperitoneum, head and neck, and viscera, respectively. Overall, 49% of patients had undergone prior suboptimal surgeries at community hospitals. Common histology subtypes were synovial sarcoma (18%), undifferentiated pleomorphic sarcoma (UPS) (13%), dermatofibrosarcoma protuberans (12%), and liposarcoma (9%). A pathological discordance of 13% was identified between the initial and the final histologies. Overall, 61% of tumors were high-grade. Memorial Sloan Kettering Stages II and III were present in 33% and 35% of patients, respectively. CONCLUSIONS: This is one of the largest single institutional experiences of STS from the Asian population. Mostly young adults were affected with male preponderance. The lower extremity and trunk were common subsites. Frequent histologies were synovial sarcoma and UPS. A high rate of suboptimal surgical intervention at the community level and pathological discordance was noted. This study highlights the need to establish prospective structured databases for capturing quality information related to rare malignancies and providing insights for future research.

Peer reviewers from low- and middle-income countries(LMIC) for open access journals in oncology can improve the equity in cancer research and clinical trials.

Open access journals (OAJ) in biomedicine are promoted to improve the reach and distribution of global health research (GHR). However, in the last 20 years, article publishing charge (APC) is attracting and publishing the vast majority of papers from high-income countries (HIC) in "oncology" journals under OAJ. This paper outlines the impediments for cancer research and publication from low-and middle-income countries (LMIC): (a) existing disparities in cancer care facilities and survival outcomes between HIC and LMIC, (b) more than 70 % of OAJ in 'oncology' subject levy APC, becoming unaffordable for scientists and clinicians from LMIC, (c) impactful OAJ in oncology engage less than 10 % of members from LMIC in editorial board or as peer reviewer, whereas two-third of cancer diagnosis and management occur in these countries. Peer review serves the editors by recommending the relevant papers. Thus, peer reviewers from developing countries working for the OAJs in "oncology" can increase the diversity in publication, improving the GHR in cancer management. The cancer research and clinical trials which can bring to notice the challenges and hurdles faced by researchers, clinicians and cancer patients in LMIC will be served to some measure by engaging peer reviewers from those countries who understand the ecosystem.

Oligometastatic breast cancer: An institutional analysis.

Introduction: Oligometastatic represents a distinctive subset of metastatic breast cancer (MBC). Incidence has been reported, in 1-5% of all newly diagnosed MBC. Literature is very sparse, especially from India. Material and Methods: We have ambispectively screened 500 patients of upfront female MBC between the period of January 2013 and August 2018 at Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi and 120 patients of oligometastatic breast cancer (OMBC) were included for analysis. Clinical, pathological, receptor status (ER estrogen receptor, PR progesterone receptor, and HER2/neu human epidermal growth factor), radiological, treatment, and survival details were recorded. Results: The median age of presentation was 50 (range 22-78) years. One organ was involved in 96 (80%) patients, and two organs were involved in 36 (20%) patients. ER and/or PR was positive in 48 (40.0%), ER/PR, and HER2/neu were positive in 28 (23.3%) cases. Only HER2/neu was positive in 21 (17.5%), and triple negativity was seen in 23 (19.2%) patients. Ninety-four (78.3%) patients received neoadjuvant therapy, and 12 (10%) patients underwent conservative breast surgery. The overall response rate at the metastatic site was 74.1%, and a complete response was seen in 42.5% of patients. Median progression-free survival (PFS) for the cohort was 25.43 months. The estimated PFS at 2 years and, at 5 years, was 54.6% and 21.6%, respectively. The hormone receptor positivity, bone metastasis, and patients with surgery after neoadjuvant chemotherapy (NACT) had a statistically significant better PFS on multivariate analysis. In a subset analysis of HER2/neu receptor-positive patients, who received targeted therapy showed better PFS compared to those who did not receive. Conclusion: The incidence of OMBC is 24% of the total MBC. The patients with OMBC who have hormone receptor-positive, bone-only metastasis, and surgery after NACT show a better outcome.

Comparison of hazard models with and without consideration of competing risks to assess the effect of neoadjuvant chemotherapy on locoregional recurrence among breast cancer patients.

CONTEXT: While analyzing locoregional recurrences (LRRs), it is necessary to consider distant metastasis as a competing event. Because, later one is more fatal than LRR. It may change ongoing treatment of breast cancer and may alter the chance of LRR. Although some earlier studies assessed the effect of neoadjuvant chemotherapy (NACT) on LRR, they did not use competing risk regression model for it. AIMS: To identify the risk factors and predict LRR using competing risk hazard model and to compare them with those using conventional hazard model. SETTINGS AND DESIGN: This was a retrospective study from a tertiary care cancer hospital in India. SUBJECTS AND METHODS: Data of 2114 breast cancer patients undergoing surgery were used from patient's record files (1993-2014). STATISTICAL ANALYSIS: Fine and Gray competing risk regression was used to model time from surgery to LRR, considering distant metastasis and death as the competing events. Further, cause-specific Cox regression was used to model time from surgery to LRR without considering competing risk. RESULTS: Greater than ten positive nodes (hazard ratio [HR] [95% confidence interval (CI)]: 2.19 [1.18-4.03]), skin involvement (HR [95% CI]: 2.75 [1.50-5.05]), NACT (HR [95% CI]: 1.90 [1.06-3.40]), invasive tumor in inner quadrant (HR [95% CI]: 1.78 [0.98-3.24]), and postoperative radiotherapy (HR [95% CI]: 0.52 [0.29-0.94]) were found to be significantly associated with LRR. However, conventional survival analysis ignoring competing risk overestimated cumulative incidence function and underestimated survival. Competing risk regression provided relatively more precise CI. Conclusions: Competing risks, if any, need to be incorporated in the survival analysis. NACT was found to be associated with higher risk for LRR, which may be because of administering it mainly to patients with bad prognosis. CONCLUSIONS: Competing risks, if any, need to be incorporated in the survival analysis. NACT was found to be associated with higher risk for LRR, which may be because of administering it mainly to patients with bad prognosis.

Modified gemcitabine and oxaliplatin or gemcitabine + cisplatin in unresectable gallbladder cancer: Results of a phase III randomised controlled trial.

AIM: To determine equivalence of modified gemcitabine and oxaliplatin compared with gemcitabine and cisplatin in unresectable gallbladder cancer (GBC). Primary end-point was overall survival (OS). METHODS: Open label, prospective, randomised phase III equivalence study. Inclusion criteria included histologically proven unresectable GBC, 18 years or older, adequate organ functions and Eastern Cooperative Oncology Group ≤2. SAMPLE SIZE: 108 patients were required in each arm to have an equivalence margin of ±2 months with power of 80%. TREATMENT: Modified gemcitabine and oxaliplatin (mGemOx)-gemcitabine 900 mg/m2, oxaliplatin 80 mg/m2, maximum 6 cycles; gemcitabine + cisplatin (CisGem)-gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, maximum 8 cycles, all day 1 and 8 every 3 weeks. RESULTS: Two hundred sixty subjects were recruited between February 2011 and July 2015. Two hundred forty-three patients (119, mGemOx and 124, CisGem) received at least 1 dose and analysed for safety and efficacy (modified intention to treat). Median OS was 8·5 months for whole group (95% confidence interval [CI]: 7·9-9·1). Median OS in mGemOx was 9 months and 8·3 months in CisGem; p = 0·057 (hazard ratio = 0·78; 95% CI = 0·60-1·02). Restricted mean OS for follow-up limited to 30 months was 11·2 months (95% CI: 9·8-12·6) in mGemOx and 10·4 months (95% CI: 9·1-11·7) in CisGem. Difference of the mean was 0·8 months with 95% CI, exceeding 2 months (-1·1 to 2·7), hence rejecting equivalence. Peripheral neuropathy, thrombocytopaenia in mGemOx and nephrotoxicity was higher with CisGem. CONCLUSION: This trial failed to show equivalence of eight cycles of CisGem to six cycles of mGemOx. Numerically OS was better with mGemOx. Toxicities were different. The trial was not powered to answer superiority. CLINICAL TRIAL REGISTRATION: CTRI/2010/091/001406.

Clinico-pathological characteristics and treatment outcome in invasive lobular carcinoma of the breast: An Indian experience.

BACKGROUND: Invasive lobular carcinoma (ILC) is the second most common histologic subtype of breast cancer and accounts for 10%-15% of all breast cancers in the west. There is a scarcity of data on ILC from the Indian subcontinent. This report intends to present the patterns of care, survival outcomes, and prognostic factors of ILC treated in a tertiary care institute. MATERIALS AND METHODS: This retrospective analysis included consecutive patients diagnosed with ILC and registered at our Institute between 2009 and 2016. RESULTS: We included 97 patients with a median age of 53 years (range 28-80). American Joint Committee on Cancer (7th edition) stage distribution was stage I-8.24%, stage II-45.36%, stage III- 34.10%, and stage IV-12.30%. Bilateral breast cancer was seen in 8 cases. Estrogen receptor, progesterone receptor, and HER 2/neu positivity was 90%, 85%, and 9%, respectively. Triple-negative breast cancer constituted 5% of cases. Twenty-nine events were recorded (systemic and locoregional relapse) with a median follow-up of 3.5 years. Three years relapse-free survival (RFS) and overall survival were 80% and 60%, respectively. Bones were the most common site of metastasis. Age <45 years [HR-1.4 (0.8-2.1), P < 0.001] and advanced clinical tumor stage [T4, HR-2.1 (1.1-3.8), P = 0.001] were associated with poor RFS. CONCLUSION: ILC constituted 2.5% of breast cancer cases at our institute. Triple negativity and HER-2/neu positivity were seen in 9% and 5% of cases, respectively. Age <45 years and advanced clinical tumor stage were associated with poor RFS.

Gall bladder cancer and the role of dietary and lifestyle factors: a case-control study in a North Indian population.

Most patients with gall bladder cancer (GBC) present in the advanced stage with a poor response to therapy. Prevention or early detection is the best way to prevent death, but this requires identification of susceptible subgroups. Keeping this in mind, this study was carried out to evaluate the association between selected demographic, lifestyle, and dietary factors and GBC. A hospital-based case-control study was carried out at the All India Institute of Medical Sciences (New Delhi, India). Cases were defined as newly registered confirmed primary GBC patients. Controls were defined as healthy relatives of patients other than that of GBC. Data were collected from February 2008 to October 2009 using a semistructured interview schedule from both cases and controls. Analysis was carried out using SPSS version 15 and Epi-Info version 6. Factors found to be significant in the bivariate analysis were entered in a multivariate logistic regression analysis. A total of 122 cases and 122 controls were included in the study. There was no significant difference in age (P=0.06) and sex (P=0.66) between the cases and the controls. In the bivariate analysis, factors found to be significantly associated with GBC were illiteracy [odds ratio (OR) 8.00, P=0.000], lower socioeconomic status (OR 2.45, P=0.000), parity more than 3 (OR 9.06, P=0.000), age at first pregnancy less than 20 years (OR 2.03, P=0.018), and the use of nonliquefied petroleum gas cooking fuel (OR 4.17, P=0.000). Higher vitamin C intake had a protective effect (OR 0.33, P=0.004). In the multivariate analysis, education, intake of vitamin C, parity, and type of fuel used were significant factors. The risk factors for GBC that have been identified in the present study delineate a high-risk population group that can be targeted for preventive measures including improvement in socioeconomic status, education and lifestyle, and dietary intervention, and avoidance of the use of nonliquefied petroleum gas as cooking fuel.

Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study.

PURPOSE: We designed this study to evaluate efficacy of modified gemcitabine and oxaliplatin (mGEMOX) over best supportive care (BSC) or fluorouracil (FU) and folinic acid (FA) in unresectable gall bladder cancer (GBC). PATIENTS AND METHODS: Patients with unresectable GBC were enrolled for single center randomized study. Arm A, BSC; arm B, FU 425 mg/m(2) and FA 20 mg/m(2) intravenous (IV) bolus weekly for 30 weeks (FUFA); arm C, gemcitabine 900 mg/m(2) and oxaliplatin 80 mg/m(2) IV infusion on days 1 and 8 every 3 weeks for maximum of six cycles. Eighty-one patients were randomly assigned, arms A (n = 27), B (n = 28), and C (n = 26). RESULTS: Complete response plus partial response in the three groups was 0 (0%), four (14.3%), and eight (30.8%) respectively (P < .001). Two patients in the mGEMOX arm and one patient in the FUFA arm underwent curative resection after chemotherapy. One patient in the mGEMOX arm had complete pathologic response. Median overall survival (OS) was 4.5, 4.6, and 9.5 months for the BSC, FUFA, and mGEMOX arms (P = .039), respectively. Progression-free survival (PFS) was 2.8, 3.5, and 8.5 months for the three groups (P < .001). There was no difference in grade 3/4 toxicities in the chemotherapy arms except transaminitis, which was more prevalent in mGEMOX arm (P = .04). Two patients in the FUFA arm and 10 patients in the mGEMOX arm had grade 3 or 4 myelosuppression. Two patients in the mGEMOX group had neutropenic fever that resolved with antibiotics. CONCLUSION: This randomized controlled trial confirmed the efficacy of chemotherapy (mGEMOX) compared with BSC and FUFA in improving OS and PFS in unresectable GBC.

A phase II study of gemcitabine and oxaliplatin (Oxigem) in unresectable gall bladder cancer.

PURPOSE: There is a need for effective chemotherapy protocols for gall bladder cancer (GBC). Gemcitabine has antitumor activity in pancreatic cancer. Oxaliplatin is effective in GI cancers. Based on evidence of synergy between these two, we designed this study to evaluate efficacy of this combination in unresectable GBC. DESIGN: Unresectable GBC was enrolled for single center phase II study. Drugs gemcitabine 900 mg/m2 and oxaliplatin 80 mg/m2 IV infusion (Oxigem) on days 1 and 8 every 3 weeks for a maximum of six cycles or unacceptable toxicity which ever was earlier. MATERIALS AND METHODS: Fifty patients were enrolled and analysis was restricted to 48 who were treated. Median age was 50 years and 31 patients were females. RESULTS: CR 3 (6.2%), PR 7 (15%), SD 17 (35.4%), and PD 18. One had complete pathological response. Median OS and PFS were 7.5 and 3 months, respectively. OS in responders was 10.5 versus 4 months in non-responders (p<0.0000). Eleven patients (23%) survived for a year or more. There was no toxic death and grade III/IV toxicity seen in 10 (22%) patients: diarrhea 3, vomiting 2, neutropenia and thrombocytopenia 5 patients. CONCLUSION: This combination of Oxigem effective in unresectable GBC. It may even induce complete pathological response. One-year survival was 20%. There is a need for controlled trial to assess efficacy of this combination.

Fallacies of preoperative lymphoscintigraphy in detecting sentinel node in breast cancer.

BACKGROUND: Preoperative lymphoscintigraphy is one of the three methods of evaluating sentinel nodes in patients with breast cancer; however, it has been reported to have a high false negative rate. CASE PRESENTATIONS: We report here two cases where the preoperative lymphoscintigraphy was found to be fallacious. A 44-year-old female with T2N0 breast cancer underwent preoperative lymphoscintigraphy with Tc99 sulfur colloid which failed to show any uptake in axilla or internal mammary chain. Intraoperative scintigraphy with blue dye and hand held gamma probe identified sentinel lymph node in axilla. Another patient with T2N0 lesion underwent preoperative lymphoscintigraphy which showed a sentinel lymph node in axilla and another in supraclevicular fossa. Intraoperative scintigraphy failed to show supraclevicular node however axillary node was correctly identified. CONCLUSION: These two cases further strengthen the need to carry out triple test in identification of sentinel lymph node in patients with breast cancer. It also demonstrates the fallacies of preoperative lymphoscintigraphy.