Background: Young (40 years) breast cancers (YBC) are uncommon, inadequately represented in trials and have unique concerns and merit studying. Methods: The YBC treated with a curative intent between 2015 and 2016 at our institute were analysed. Results: There were 1228 patients with a median age of 36 (12e40) years; 38 (3.1%) had Stage I, 455 (37.1%) -II, 692 (56.3%) eIII, and remaining 43 (3.5%) Stage IV (oligo-metastatic) disease; 927 (75.5%) were node positive; 422 (34.4%) were Triple negatives (TNBC), 331 (27%) were HER-2 positive. There were 549 (48.2%) breast conservations and 591 (51.8%) mastectomies of which 62 (10.4%) underwent breast reconstruction. 1143 women received chemotherapy, 617 (53.9%) received as neoadjuvant and 142 (23.1%) had pathological complete response; 934 (81.9%) received adjuvant radiotherapy. At the median follow-up of 48 (0e131) months, 5-year overall and disease-free survival was 79.6% (76.8e82.5) and 59.1% (55.8e62.6). For stage I, II, III and IV, the 5-year overall-survival was 100%, 86.7% (82.8e90.6), 77.3% (73.4e81.2), 69.7% (52.5e86.9) and disease-free survival was 94% (85.9e100), 65.9% (60.3e71.5), 55% (50.5e59.5), and 29.6% (14e45.2) respectively. On multivariate analysis, TNBC and HER-2þ subgroups had poorer survival (p ¼ 0.0035). 25 patients had BRCA mutations with a 5-year DFS of 65.1% (95% CI:43.6e86.6). Fertility preservation was administered in 104 (8.5%) patients; seven women conceived and 5 had live births. Significant postmenopausal symptoms were present in 153 (13%) patients. Conclusion: More than half of the YBC in India were diagnosed at an advanced stage with aggressive features leading to suboptimal outcomes. Awareness via national registry and early diagnosis is highly warranted. Menopausal symptoms and fertility issues are prevalent and demand special focus.
Background There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. Methods This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. Results The study included 101 female patients with median age of 57 (IQR 48–62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5–41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5–43.7) months, median PFS and OS were 5.98 (95%CI 4.96–7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3–4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25–0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20–0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008–0.206, p = 0.000) with OS. Conclusion Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.
Purpose Crizotinib has been one of the standard treatment options for the treatment of anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC) based on higher progression-free survival (PFS) and objective response rates in phase III clinical trials. However, real-world data about the long-term efficacy and toxicity of crizotinib is limited. Methods A retrospective analysis of all patients with ALK-positive NSCLC, treated with crizotinib between March 2014 and December 2016, was performed. The main outcomes measured were PFS, overall survival (OS), and adverse effects. Results One hundred and eighty-eight patients treated with crizotinib during this period were included in this study. The median age was 50 years (range: 24–74) with a majority being males (73.2%) and 80.3% with a performance status of 0 to 1. The median duration of follow-up was 49.4 months (range: 3.4–86.3%). The median PFS of crizotinib was 17.3 months (95% confidence interval [CI], 13.0–21.6) and 12.8 months (95% CI, 8.1–17.6) when used in first line or subsequent lines, respectively. The median OS was 38.3 months (95% CI, 28.4–48.2). The patients who received crizotinib in the first line had a median OS of 45.5 months (95% CI, 29.6–61.4) as compared with 29.7 months (95% CI, 22.2–37.2) for those who received in subsequent line (hazard ratio, 0.6, 95% CI, 0.4–0.9, p=0.022). The most common all grade toxicities include transaminitis, anemia, fatigue, and corrected QT prolongation. Conclusion This real-world study confirms the long-term beneficial effects of crizotinib in ALK rearranged NSCLC with favorable toxicity profile like that of the registration studies, in resource constrained settings.
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