BackgroundThe present study evaluated the real-world experience with cyclin dependent kinase 4/6 inhibitors palbociclib and ribociclib in hormone receptor-positive/ human epidermal growth factor receptor 2-negative (HR + /HER2-) metastatic breast cancer.MethodThis study was conducted on the HR + /HER2- metastatic breast cancer patients who received palbociclib/ ribociclib in the first line or recurrent setting between January 2021 and January 2023 along with endocrine therapy. Data was retrieved from the Hospital medical records.ResultsIn the patients receiving palbociclib, a better median progression free survival (PFS) was observed in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 1 (27.3 months,p-value <0.0001), de novo disease (17.5 months,p-value 0.0155), first line hormonal therapy (22.5 months,p-value <0.0001) and no prior chemotherapy (20.3 months,p-value 0.0001). Similarly, in the patients receiving ribociclib, a better median PFS was observed in patients with ECOG PS 1 (22.2 months,p-value <0.0001), de novo disease (21.7 months,p-value 0.0042), first-line hormonal therapy (22.5 months,p-value <0.0001) and no prior chemotherapy (21.7 months,p-value <0.0001). On multivariate analysis, ECOG PS, line of hormone therapy and prior chemotherapy showed significance (p-values <0.0001, < 0.0001 & 0.0269, respectively).ConclusionThe study shows real-world experience with cyclin dependent kinase 4/6 inhibitors palbociclib and ribociclib in metastatic breast cancer in India.

In a real-world setting, this study evaluated clinical parameters and outcomes with the administration of eribulin in heavily pre-treated Indian metastatic breast cancer (MBC) patients using electronic medical records. Among 145 patients, 46.2% were oestrogen/progesterone receptor-positive, 15.9% had HER2-overexpression, and 46.2% had triple-negative breast cancer (TNBC). Eribulin was administered as a 2nd, 3rd, 4th, and ≥5th line chemotherapy in 11.7%, 18.6%, 30.3%, and 39.3% patients, respectively. Grade ≥3 neutropenia occurred in 26.2% of patients. After six cycles, 1.8% had complete response, 17.5% partial response, 17.5% stable disease, and 57.9% experienced disease progression. The overall response rate was 7.6%. Median progression-free survival and overall survival were 3.9 and 11.6 months, respectively. Overall, the study shows low response rate with manageable toxicity. The findings highlight the need for further focused studies comparing eribulin with existing chemotherapies, especially in the Indian patients with disease heterogeneity and unique genetic makeup.

CONTEXT:The role of androgen receptor (AR) as a prognostic marker in triple negative breast cancer (TNBC) has been ambiguous since existing reports illustrate conflicting results. AIMS:To compare clinicopathological features and survival between AR-positive TNBC and QNBC. METHODS AND MATERIAL:A total of 281 subjects were included and tissue microarrays (TMA) were constructed using tumor tissue cores from their formalin-fixed paraffin-embedded blocks. The testing of AR expression was done using immunohistochemistry on TMA slides. Tumors with at least 1% nuclear staining were considered to be positive for AR expression. Comprehensive data were gathered from electronic medical records and analyzed using statistical tests. RESULTS:The expression of AR was positive in 52 cases. The TNBC subgroup with a positive family history of cancer had a significantly higher frequency (P = 0.011) of second primary occurrence. AR expression was significantly associated with higher age at diagnosis (P = 0.006), smaller tumor size (P = 0.033), lower tumor grade (P < 0.001), non-basal-like phenotype (P < 0.001), and distant recurrence (P = 0.024). At a median follow-up period of 88 (range 0-137) months, a 10-year disease-free rate was higher in quadruple negative breast cancer (QNBC) (78% vs. 73%) compared to AR-positive TNBC. Likewise, the 10-year overall survival rate in QNBC was superior (75% vs. 72%) to AR-positive TNBC. CONCLUSIONS:AR is expressed in one-fifth of all TNBC. AR expression is associated with smaller tumor size, lower tumor grade, higher age, and distant recurrence. AR-positive TNBC exhibits shorter disease-free survival and overall survival than QNBC.

Background Global phase III trials demonstrated efficacy of abemaciclib in patients with HR +/HER2– metastatic breast cancer (BC) as a first-line therapy in combination with a nonsteroidal aromatase inhibitor (MONARCH-3) or with fulvestrant following progression after endocrine therapy (ET) (MONARCH-2). However, there is limited data on safety and tolerability of abemaciclib plus ET in the metastatic BC setting among Indian patients, which the present study aims to address. Materials and Methods An open-label, single-arm, phase IV study was conducted across 16 centers in India to assess the safety and tolerability of abemaciclib in patients with HR +/HER2– locally advanced or metastatic BC. Patients were assigned to either cohort A, ET-naive patients (abemaciclib + anastrozole/letrozole) or cohort B, patients progressing after previous ET (abemaciclib + fulvestrant), targeting the same patient population as the global phase III MONARCH-3 and MONARCH-2 trials, respectively. Primary endpoints were all-cause adverse events (AEs) including serious AEs (SAEs). Statistical Analysis The statistical analysis was conducted using SAS Version 9.4. Results Two hundred patients were enrolled, with a mean age of 54 years, most (77.0%) were aged ≤ 65 years. The median duration of exposure was similar in both cohorts (cohort A vs. B: 24.3 vs. 24.4 weeks). Overall, 75.5 % of patients reported all-cause AEs, of which 38.5% of the patients reported AEs Common Terminology Criteria for Adverse Events grade 3 and above. The most common grade 3 and above all-cause AEs for abemaciclib were neutropenia (19.0%), followed by anemia (14.0%) and diarrhea (5.5%). Fourteen (7.0%) patients encountered SAEs, including infections (2.0%) and gastrointestinal disorders (1.5%). Most of the patients continued their treatments with appropriate dose reductions (25.5%) and dose omissions (40.5%), and only 2.5% of patients discontinued study treatment due to treatment-related AEs. Conclusion Abemaciclib in combination with ET was found to have an acceptable tolerability in Indian patients with HR +/HER2– advanced and metastatic BC, consistent with the established safety data as reported in the pivotal global studies. No new clinical safety concerns were identified, with most of the reported AEs and SAEs managed by dose adjustments.

Gemcitabine–cisplatin doublet is a standard first-line regimen for metastatic gallbladder cancer (GBC), though prospective real-world data remains scarce. We evaluated the efficacy, safety, and prognostic factors in the North Indian patients. Between March 2021 and December 2022, all patients with histologically proven metastatic GBC were prospectively enrolled. Eligible patients had ECOG 1–2 and adequate organ function. Gemcitabine 1000 mg/m² (days 1, 8) and cisplatin 75 mg/m² (days 1–2) were given every 3 weeks for up to 6 cycles, until progression or intolerance. Patients receiving ≥ 2 cycles were evaluable for efficacy. Responses were assessed by RECIST 1.1. Kaplan–Meier, univariate, and multivariate analyses were performed. Sixty-three patients were included in the study (Mean Age 56 years; 62

INTRODUCTION:Trastuzumab emtansine (T-DM1), an antibody-drug conjugate, targets tumor cells overexpressing human epidermal growth factor receptor 2 (HER2). This single-arm, phase IV study assessed the safety and efficacy of T-DM1 in Indian patients with HER2-positive, locally advanced, or metastatic breast cancer previously treated with trastuzumab and a taxane. METHODS:Patients received T-DM1 (3.6 mg/kg intravenously every 3 weeks) until death, disease progression, unacceptable toxicity, consent withdrawal, or up to a maximum of 12 months after the last patient's first visit, whichever occurred first. Safety was mainly assessed by the incidence and severity of adverse events (AEs). Efficacy was evaluated by progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). Patients were followed up posttreatment until 12 months or until lost to follow-up, withdrawn consent, or death. RESULTS:A total of 70 eligible patients (median age [range]: 50.0 [27.0-75.0] years) received at least one dose of T-DM1 (median duration [range]: 32.0 [1.0-125.0] weeks). Adverse events in 21 (30.0%) patients were treatment-related. The most common treatment-related AEs and SAEs were thrombocytopenia (seven [10.0%] and three [4.0%] patients, respectively) and epistaxis (four [6.0%] and two [3.0%] patients, respectively). During the study, 10 (18.0%) patients died (disease progression: n = 6; AE: n = 3; and unknown reason: n = 1), while 2 patients died during the follow-up period. Median PFS was 14 months (95% confidence interval [CI]: 8.0, 17.0). Among 65 evaluable patients, 16 (23.0%) achieved partial responses; ORR was 23.0%. CONCLUSIONS:Trastuzumab emtansine was found to be safe and efficacious in the Indian patients.

Introduction Several methods, such as multi-marker (both gene/protein) tests and online/free tools, are available for the prognostication of early breast cancer (EBC) patients. This article compares the risk assessment between the immunohistochemistry-based (IHC) CanAssist Breast (CAB) test and the online/free prognostic tool PREDICT in EBC patients treated at Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC) between May 2017 and June 2022. Methodology The current study cohort comprises 130 patients. Risk proportions were assessed by CAB and the online/free tool PREDICT. Concordance between the risk groups of CAB and PREDICT was assessed by the kappa coefficient, which was used to evaluate the significance. Results The low-risk (LR) and high-risk (HR) proportions for CAB and PREDICT were 61:39 and 46:54 percent, respectively. CAB stratified a significantly (P=0.027) higher number of patients as LR compared to PREDICT. Interestingly, in the subgroup analysis of the age and clinicopathological parameters CAB stratified 28% of patients with grade 3 tumors as LR, whereas PREDICT stratified all grade 3 tumors as HR. The overall treatment compliance using CAB was 89%. Conclusion CAB, a relatively new multi-marker prognostic test entailing five relevant protein biomarkers provides augmented and relevant prognostic information over PREDICT in all patients. Thus, CAB helps optimize treatment for HR+/HER2- EBC patients as its risk stratification is independent of age and clinical parameters and assigns recurrence risk based on tumor biology.

1009 Background: Trastuzumab deruxtecan (T-DXd) is approved for adult patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) who received a prior anti-HER2–based regimen. DESTINY-Breast07 is a Phase 1b/2 multicenter, open-label, modular study exploring the safety, tolerability, and antitumor activity of T-DXd alone or in combination with other anticancer agents (NCT04538742). These results are from an interim analysis of the dose-expansion phase assessing T-DXd ± pertuzumab (P) as first-line (1L) treatment in HER2+ mBC. Methods: Pts had locally assessed HER2+ mBC with measurable disease and no or stable brain metastases. A disease-free interval of ≥12 months from (neo)adjuvant therapy was required; no prior therapy for mBC was allowed. Pts were stratified by hormone receptor and disease status (recurrent vs de novo), and PD-L1 expression. Pts received T-DXd 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W) as monotherapy or in combination with P 420 mg IV Q3W, with an 840 mg loading dose. Primary endpoints were safety and tolerability; key secondary endpoints included objective response rate (ORR) and progression-free survival (PFS), per RECIST 1.1 by investigator. Results: Seventy-five pts were treated in the T-DXd module and 50 pts in the T-DXd + P module; median follow up was 19.2 months (range 8.7–29.2) and 20.6 months (range 13.3–26.7), respectively. Median age was 57 years in both modules. As of August 1, 2023, the most common adverse event (AE) was nausea (T-DXd, 70.7% [4.0% Grade 3]; T-DXd + P, 68.0% [0% Grade 3]). Diarrhea was reported in 34.7% (2.7% Grade 3) and 60.0% (6.0% Grade 3) of pts in the T-DXd and T-DXd + P modules, respectively. There were no Grade ≥4 nausea or diarrhea events. Adjudicated drug-related interstitial lung disease (ILD) / pneumonitis was reported in six (8.0%) and five (10.0%) pts in the T-DXd and T-DXd + P modules, respectively (all Grade ≤2). One non-treatment-related AE with outcome of death was reported in the T-DXd module (post-acute COVID-19 syndrome); none with T-DXd + P. The confirmed ORR was 77.3% (80% confidence interval [CI] 70.0, 83.6) with T-DXd and 82.0% (80% CI 73.1, 88.8) with T-DXd + P. PFS rate at 12 months was 77.3% (80% CI 69.0, 83.7) with T-DXd and 89.4% (80% CI 81.9, 93.9) with T-DXd + P. Conclusions: Safety profiles were consistent with the known profiles for T-DXd and P, with no Grade ≥3 ILD events. Early data showed promising efficacy in both modules. The DESTINY-Breast07 study is ongoing; analyses from the Phase 3 DESTINY-Breast09 clinical trial will provide definitive data on TDXd ± P in 1L HER2+ mBC. Clinical trial information: NCT04538742 . [Table: see text]

e13003 Background: Patients in thehormone receptor positive/ herceptin2- (HR+/HER2-) subset have better prognosis among all molecular sub types of breast cancer, however, most patients ultimately progress on treatment with traditional endocrine therapies. The present study was conducted to evaluate the real world experience with Cyclin dependent kinase (CDK) 4/6 inhibitors Palbociclib and Ribociclib by evaluating the efficacy and toxicity profile in HR+/HER2- metastatic breast cancer. Methods: Thisstudy was conducted on the HR+/HER2- metastatic breast cancer patients who received Palbociclib/ Ribociclib in the first line or recurrent setting between January 2021 and January 2023 along with endocrine therapy. Clinical and demographic information and survival data was retrieved from the Hospital medical records. Results: Among a total of143 patients, 93 and 50 patients had received Palbociclib and Ribociclib, respectively. The most common factors in both the groups were age group 45-64 years (65.7%), postmenopausal status (65.7%), ECOG Performance status 1 (46.2%) and denovo disease at presentation (58%). The overall response rate was 90.2%. Majority of the patients showed partial response (64.3%) followed by stable disease (20.3%) in either group. In the patients receiving Palbociclib, a better median progression free survival (PFS) was observed in patients with ECOG performance status (PS) 1 (27.3 months, p-value < 0.0001), denovo disease (17.5 months, p-value 0.0155), first line hormonal therapy (22.5 months, p-value < 0.0001) and no prior chemotherapy (20.3 months, p-value 0.0001). Similarly, in the patients receiving Ribociclib, a better median PFS was observed in patients with ECOG PS 1 (22.2 months, p-value < 0.0001), denovo disease (21.7 months, p-value 0.0042), first line hormonal therapy 22.5 months (p-value < 0.0001) and no prior chemotherapy (21.7 months, p-value < 0.0001). On multivariate analysis, the factors significantly associated with PFS were ECOG PS, line of hormone therapy and prior chemotherapy (p-values < 0.0001, < 0.0001 & 0.0269, respectively). Anaemia & transaminitis were the most common toxicities in both drug cohorts [Palbociclib (97.8% & 75.3%, respectively) & Ribociclib (96.5% & 82%, respectively). Overall, dose modification due to toxicity was not required in 67.8% patients. Conclusions: The present study shows the real world experience with the effectiveness and tolerability of CDK inhibitors in metastatic breast cancer in India. However, large scale multi-centric studies are required to evaluate the pan India experience with these inhibitors.

Background Clinicians use prognostic biomarker/multi-gene-based tests for predicting recurrence in hormone receptor-positive/HER2-negative (HR+/HER2-) early-stage breast cancer (EBC). CanAssist Beast (CAB) uses the expression of five protein biomarkers in combination with tumor-specific parameters such as tumor size, histopathological grade, and lymph node status to predict the risk of distant recurrence within five years of diagnosis for patients with HR+/HER2-, EBC. The current study aimed to evaluate the impact of prognostic tests on adjuvant chemotherapy decisions by assessing the agreement between clinical and CAB risk stratification as low-risk (LR) or high-risk (HR) for distant recurrence. Methods The primary study group included 300 patients with HR+/HER2-, EBC diagnosed between 2016 and 2021. The clinical risk assessment and recommended treatment plan were captured before and after receiving the results for CAB. The risk stratification of patients into CAB LR and HR was obtained. Finally, compliance with CAB was analyzed by assessing the concordance of treatment prescribed with the CAB risk category. Results Before performing the CanAssist Breast test, patients were stratified based on clinicopathological features, with 52% of patients as LR, 21% as HR, and 27% of patients distributed as uncertain/intermediate risk (IR) category. CAB re-stratified the same cohort of patients, 67% as LR and 33% as HR, which was 15% higher than that of clinical LR assessment. The clinical IR category was re-stratified by CAB as 51% LR and 49% HR. Changes in treatment recommendations were seen in both clinical HR and clinical LR groups, which were 87% and 85%, respectively. Conclusions CAB has a significant impact on chemotherapy decisions. CAB provides definite treatment recommendations for patients with clinical intermediate risk. Overall, CAB has changed treatment recommendations in 23% of the cohort and for 88% of clinical IR patients helped physicians make a treatment decision.

Background The widespread use of oxaliplatin plus infusional 5-fluorouracil (5-FU) and folinic acid (FOLFOX) in advanced gastric cancers is mainly based on clinical trials conducted at Western/European countries. The prospective data on efficacy and safety of FOLFOX in advanced gastric cancer is lacking from the developing countries. In this prospective observational study, we evaluated the efficacy and toxicity of mFOLFOX-6 in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinomas, as first-line palliative chemotherapy. Methods Patients with previously untreated metastatic adenocarcinoma of stomach/GEJ, received mFOLFOX-6 (2 hours infusion of oxaliplatin [85 mg/m2] and folinic acid [400 mg/m2], followed by fluorouracil 400 mg/m2 intravenous push, then a 46-hour continuous infusion of 5-FU [2,400 mg/m2]). Cycles were repeated every 2 weeks. The patients were prospectively followed up for response rates and toxicity. Results Sixty-six patients were included in the study with a median age of 57 years. Sixty-two patients were evaluable for response. The overall response rate was 53%, with a disease control rate (overall response and stable disease) of 81.8%. The median progression-free survival was 6 months (95% confidence interval [CI] 5.2–6.7 months) and the median overall survival was 11.5 months (95% CI 9.0–13.9 months). Ascites at presentation and more than one site of metastasis are associated with significantly lower survival on the log-rank test. Gastrointestinal and hematological toxicities were predominant, with rates of grade 3 to 4 nausea/vomiting (13.6%), anemia (15.1%), and neutropenia (13.6%). Among other toxicities, neurosensory toxicities were common. Four (6%) patients had grade 3 peripheral neuropathy. Conclusion mFOLFOX-6 is an active and well-tolerated chemotherapy regimen in advanced adenocarcinoma of stomach/GEJ. This regimen has similar response rates and treatment outcomes with lesser grade 3 or 4 toxicities than that of triplet regimens compared to historical studies.

The molecular pathogenesis of breast cancer (BC), the second most common cancer, varies significantly between sexes, with minimal data in the transgender population. The overall prevalence of BC in transgenders is estimated to be 0.02%. Besides experiencing social disparities, transgenders have to face a lot of discrimination in the healthcare system. Adversities faced, along with the urge to identify with physical attributes to the gender felt by them, forces transgenders to use non-prescribed hormones. Gender affirming hormone therapy (GAHT) is a key feature of transition-related care, rehabbing mental health, and the quality of life of transgenders, but at the expense of their health. Studies have reported that GAHT is associated with severe health conditions such as cancer in transgenders. Estrogens and testosterone are associated with a moderate risk of developing BC. The types of BC diagnosed in transgenders after cross-sex hormone therapy include invasive ductal and neuroendocrine carcinoma, in addition to tubular adenocarcinoma. Although diagnosed at an age earlier compared with ciswomen, BC screening recommendations for transgenders are the same as for ciswomen. This review studies in detail the types of transgenders, their characteristics, different types of breast cancers associated, issues faced while treatment, and their best possible solutions. We also hope to have well-designed research in the future, which will fill the existing gaps in knowledge and provide scientific insight into the transgender population and issues related to their health. There are no international guidelines on screening and management of transgender patients but it appears that breast screening before cosmetic mastectomy, exposure to hormonal therapy for more than 5 years, and as per natal women screening guidelines should be offered to the patient with detailed discussion on the harms and benefits of the same.

e13002 Background: Eribulin is a synthetic non-taxane anti-microtubule agent approved in India for the second line of treatment of locally advanced or metastatic breast cancer. Eribulin has shown to improve overall survival (OS) in various subgroups of patients with metastatic breast cancer (MBC) who were pretreated with an anthracycline and taxane. However, efficacy and safety data for eribulin in Indian patients with MBC is limited. Therefore, this real world study assessed the clinical outcomes of eribulin in heavily pre-treated MBC Indian females. Methods: Histologically confirmed adult MBC patients who received eribulin over several lines of therapy were retrospectively analysed. Socio-demographic, clinical, pathology, imaging, and therapy records were reviewed. The progression-free survival (PFS), overall survival (OS), tumor response and safety were evaluated. Results: A total of 189 patients were included and out of these patients 145 patients were analysed. The median age of patients was 52 years (range: 28-71). Eribulin was used as a 2 nd , 3 rd , 4 th and ≥ 5 th line chemotherapy agent in 17 (11.72%), 27 (18.62%), 44 (30.34%) and 57(39.31%) of MBC patients, respectively. In the overall population, the objective response rate (ORR) was 7.58%, while the clinical benefit rate (CBR) was 15.48%. The median PFS and OS were 3.86 (95% CI: 3.18-4.54) and 11.56 (95% CI: 8.72-14.40) months respectively. There was positive correlation between the number of eribulin cycles and the outcomes of survival, with patients getting more than 3 cycles having significantly superior OS and PFS. On subgroup analysis, there was no significant difference in the outcomes of survival on the basis of hormone receptor and her-2 status, however the patients who had more than 3 metastatic sites had significantly lower survival outcomes. The anthracycline and taxane refractory (progression within 6 months after their last anthracycline/taxane dose) patients had significantly (p<0.001) lower median PFS as compared to anthracycline and taxane sensitive patients (2.96 months vs 5.23 months) and (2.86 months vs 4.46 months) respectively. Among the grade ≥3 toxicities, neutropenia was 26.21%, anemia was 13.10%, thrombocytopenia was 6.21% and mucositis was 8.97%. The grade ≥2 peripheral neuropathy was seen in 28.97% patients and 21.38% patients had gastro-intestinal symptoms. Conclusions: This study confirms that Eribulin is effective and has manageable toxicity in patients with MBC. It should be considered as the strategy of several chemotherapy lines in MBC.

BACKGROUND:Advanced gastric cancer is associated with poor survival despite chemotherapy. Maintenance chemotherapy has been successfully tried in lung cancer and colorectal cancers however there is scarce literature on maintenance therapy in advanced gastric cancer. We report a prospective non-randomized single-arm trial of capecitabine maintenance after response to docetaxel, cisplatin, and 5-Flurouracil-based chemotherapy.METHODS:50 patients with advanced gastric cancer, who had achieved response or had stable disease after 6 cycles of Docetaxel, Cisplatin, and 5-Flurouracil (D 75 mg/m2, C 75 mg/m2, FU 750 mg/m2/d d1-d5, q3 weeks) chemotherapy were prospectively selected to receive maintenance chemotherapy with capecitabine (1000mg/ m2 bid d1-d14 q21 days) until progression.RESULTS:During the median follow-up period of 18 months all patients had progressed, however, there was no treatment-related death, the median time to tumor progression was 10.3 months, with grade 3 and 4 toxicities in 10-15% of patients, and treatment delays in 75% of patients.CONCLUSIONS:Our study has shown that maintenance chemotherapy with capecitabine post-first-line docetaxel, cisplatin, and 5-FU-based chemotherapy is effective and delays tumor progression. However, toxicity was a concern in our study which led to treatment-related delays but without any treatment-related death. Most patients continued therapy till progression.

Background: Osteosarcoma represents the commonest category of bone tumors in the children and young adults and stability in its incidence rates have been observed throughout the world. The present study evaluated the varied profile of Indian patients with osteosarcoma with a special emphasis on the survival patterns in a tertiary cancer care centre in India.

Background Circulating tumor cells (CTCs) in the peripheral blood may play a major role in the metastatic spread of breast cancer. This study was conducted to assess the role of CTCs to determine the prognosis in terms of survival in metastatic breast cancer patients. Methods This prospective study of 36 patients was conducted at the Hospital from April 2016 to May 2018. Details of each patient related to the demographic profile, tumor type, treatment, and follow-up information were recorded. The number of CTCs in the peripheral blood was measured by Celsee PREP 400 sample processing system and Celsee Analyzer imaging station. Results There was a positive correlation between the number of site of metastasis with number of CTCs (p -value < 0.001). In the patients with clinical/partial response, a significant reduction in the number of CTCs after 1 month of therapy was observed (p -value = 0.003). When the number of CTCs at baseline and 6 months were compared with the positron emission tomography response at 6 months, a statistically significant difference in CTCs in patients having partial response after 6 months was observed (p -value = 0.001). On comparison with the responder groups, a statistically significant reduction in CTCs at baseline and 6 months was observed (p -value = 0.001). Patients with CTCs less than 5 and more than or equal to 5 after 1 month of treatment had a mean progression-free survival of 11.1 months and 7.5 months (p-value = 0.04) and a mean overall survival of 11.6 and 9.6 months (p-value = 0.08), respectively. Conclusion Assessment of CTCs provides a more quantifiable response than radiographic evaluation and at a much earlier time point and is also a better predictor of survival.

Management of Her-2 negative breast cancer is evolving. Literature on response and outcomes to neoadjuvant chemotherapy (NACT) is limited from the Indian subcontinent. In this study, we evaluated the pathological complete response(pCR) rates to NACT, and outcomes in Her2-negative breast cancers, which includes TNBC and hormone receptor-positive (HR+) cohorts. Her2-negative breast cancer patients who received neoadjuvant chemotherapy and then underwent surgery between January 2017 and December 2021 at a tertiary cancer hospital in India were included. Pathological response to chemotherapy, and outcomes were noted by retrospective electronic medical record review. pCR was defined as complete disappearance of all invasive carcinoma cells in the breast and axillary lymph nodes (ypT0/ypN0). Of the 1760 Her-2 negative breast cancers who were registered at our institute in the above time period, 232 patients received NACT, and 172 patients who completed NACT and then underwent surgery were included in the analysis. The median age of presentation was 50 years (Range 31-74 years). The median age was 46 years in the TNBC cohort, and 55 years in HR+ cohort. Majority of the patients received anthracycline/taxane based chemotherapy, and 94.1% (162/172) of the patients received all planned cycles of chemotherapy before surgery. Overall pathological complete response (pCR) was seen in 27.3% of patients (47/175). pCR rates were significantly higher in the TNBC cohort compared to HR+ cohort (38.2% vs 15.6 %, P - 0.001). TNBC variant and higher histologic grade (Grade III) were associated with significantly higher pCR rates. At a median follow-up of 30.8 months, 23.2% of patients (40/172) developed relapse (26.9% in TNBC, 19.2 % in HR+). Patients who achieved pCR had significantly lower chances of recurrence compared to those with non-pCR to chemotherapy (12.7% vs 27.2%, P- 0.045). Triple-negative breast cancer subtype and higher histologic grade are associated with significantly higher pathological complete response to NACT. Achieving complete pathological response is associated with lower risk of breast cancer recurrence, and it is an important surrogate marker for recurrence-free and overall survival.