Palbociclib plus letrozole as treatment for postmenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An expanded access study in Australia and India.

AIM: Palbociclib was approved in the United States in 2015 to treat estrogen receptor-positive/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). This study evaluated outcomes and safety in patients treated with palbociclib in Australia and India with hormone receptor-positive (HR+)/HER2- ABC before palbociclib became commercially available. METHODS: Postmenopausal women (≥18 years) with HR+/HER2- ABC who were appropriate candidates for letrozole therapy received palbociclib 125 mg once daily for 21 days followed by 7 days off, and letrozole 2.5 mg once daily (continuous). Safety, tumor response, and patient-reported outcomes (Australian cohort) were evaluated. RESULTS: In total, 252 patients received palbociclib plus letrozole (Australia, n = 152; India, n = 100). More patients in the Australian versus Indian cohort had received prior chemotherapy (advanced/metastatic setting: 45.9% vs. 32.0%), endocrine therapy (advanced/metastatic setting: 63.2% vs. 54.3%), and advanced/metastatic therapies (61.8% vs. 31.0%). The most frequently reported all-grade palbociclib-related treatment-emergent adverse events were neutropenia (66.7%), fatigue (35.3%), and stomatitis (26.6%); grade 3/4 neutropenia was reported as palbociclib-related in 62.7% of patients. Febrile neutropenia was reported in six patients (2.4%). Eight patients (3.2%) discontinued because of an adverse event. The objective response rate was 19.4% (95% CI, 14.7%-24.9%) overall and 2.3% in Australian patients with ≥2 lines of prior therapy for metastatic disease. Patient-reported quality of life scores were maintained throughout the study. CONCLUSIONS: In an expanded access setting in Australia and India, palbociclib plus letrozole was well tolerated in patients with HR+/HER2- ABC, with a safety profile consistent with previous reports.

Validation and assessment of voice-related quality of life in Indian patients undergoing total laryngectomy and primary tracheoesophageal puncture.

BACKGROUND: Voice-related quality of life (V-RQOL) has never been studied in Indian patients. This study was planned to validate and assess V-RQOL in patients using tracheoesophageal puncture (TEP). METHODS: A cross-sectional study was undertaken to validate V-RQOL questionnaire by testing reliability, validity, and responsiveness. V-RQOL was assessed in patients undergoing total laryngectomy with primary TEP. RESULTS: One hundred thirty-two patients filled 188 questionnaires. Analysis was carried out on 122 patients. Reliability and validity of questionnaire were tested by Cronbach's alpha (.84-.91) and item-scale correlation (.67-.86). Median V-RQOL-Total score was 76.2 indicating excellent V-RQOL. Higher scores were observed in patients less than 50 years (82.5 vs 72.5, p = .08). There was no effect of time interval between laryngectomy and assessment of questionnaire on the V-RQOL scores. CONCLUSION: V-RQOL questionnaire can be used reliably to assess V-RQOL, which is found to be excellent in Indian patients undergoing TEP.