Background: This analysis evaluated patient-reported outcomes (PROs) to assess health-related quality of life (HRQoL) in the phase III MONALEESA-7 trial, which previously demonstrated improvements in progression-free survival (PFS) and overall survival (OS) with ribociclib (cyclin-dependent kinase 4/6 inhibitor) + endocrine therapy (ET) compared with placebo + ET in pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Methods: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire C30 (QLQ-C30) and the EQ-5D-5L were used to evaluate HRQoL. Results: EORTC QLQ-C30 assessments were evaluable for 335 patients in the ribociclib arm and 337 patients in the placebo arm. Adherence rates at baseline and ⩾1 postbaseline time point were 90% and 83%, respectively. Patients treated with ribociclib + ET had a longer time to deterioration (TTD) ⩾ 10% in global HRQoL {hazard ratio (HR), 0.67 [95% confidence interval (CI), 0.52–0.86]}. TTD ⩾ 10% in global HRQoL was delayed in ribociclib-treated patients without versus with disease progression [HR, 0.31 (95% CI, 0.21–0.48)]. TTD ⩾ 10% in pain was longer with ribociclib + ET than with placebo + ET [HR, 0.65 (95% CI, 0.45–0.92)]. Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib versus placebo in global HRQoL and pain. Conclusion: HRQoL was maintained longer in patients who received ribociclib + ET versus placebo + ET. These data, combined with previously reported improvements in PFS and OS, support a strong clinical benefit-to-risk ratio with ribociclib-based treatment in pre- and perimenopausal patients with HR+/HER2− ABC.
<p class="abstract"><strong>Background:</strong> Frozen shoulder is one of the most common musculoskeletal problems seen in orthopaedics. Many treatment modes are available however, it is difficult to treat and data on the comparative efficacy of various interventions are limited. Intra-articular corticosteroid injection (IASI) is a commonly used to treat frozen shoulder pain. Supra-scapular nerve block (SSNB) is also effective method to treat pain in chronic diseases that affect the shoulder. The present study was done to compare efficacy of ultrasound guided SSNB and IASI in management of painful frozen shoulder.</p><p class="abstract"><strong>Methods:</strong> 60 patients with painful frozen shoulder were divided in two groups, Group A received ultra-sound guided SSNB with 6 ml 0.5% Bupivacaine; Group B received IASI using 40 mg Triamcinolone. Outcome measures were shoulder ranges mainly lateral rotation and abduction, shoulder pain and disability index and visual analogue scale (VAS). Patients were followed-up on 2<sup>nd</sup> day, at 1<sup>st</sup>, 3<sup>rd</sup> and 6<sup>th</sup> week.<strong></strong></p><p class="abstract"><strong>Results:</strong> All baseline parameters improved significantly in both groups; however, on comparison Group A showed significant improvement in passive lateral rotation on 2<sup>nd</sup> day and 1<sup>st</sup> week follow up (P =0.038 and 0.040 respectively). VAS score showed significance at all follow-up in Group A, whereas, in Group B significance was seen after 1 week. On inter group comparison Group A shows significance on 2<sup>nd</sup> day (P =0.050), 1<sup>st</sup> week (P =0.042) and 3<sup>rd</sup> week (P =0.036).</p><strong>Conclusions:</strong>Both SSNB and IASI have efficacy in management of frozen shoulder. But supra-scapular nerve block is better than intra-articular injection and should be considered prior to steroid as it has early onset pain relief, early improvement in ranges, potentially lesser contraindications and side effects.<p> </p>
Background: Patients (pts) with advanced breast cancer (ABC) who present with visceral metastases (mets) have a poorer prognosis vs pts with non-visceral disease. In the Phase III MONALEESA (ML) trials, ribociclib (RIB) + endocrine therapy (ET) prolonged progression-free survival (PFS) vs placebo (PBO) + ET in hormone receptor-positive (HR+), HER2-negative (HER2–) ABC. Here we show data for pts with and without visceral mets from the ML-2, -3, and -7 trials. Methods: Data were collated from 3 trials in HR+, HER2– ABC: in ML-2 (NCT01958021; data cutoff [DCO] Jan 2/4, 2017), postmenopausal pts (no prior ET for ABC) received RIB or PBO + letrozole; in ML-3 (NCT02422615; DCO Nov 3, 2017), postmenopausal pts (no prior ET for ABC subgroup only) received RIB or PBO + fulvestrant; in ML-7 (NCT02278120; DCO Aug 20, 2017), premenopausal pts (no prior ET and ≤1 chemotherapy for ABC) received RIB or PBO + goserelin + anastrozole/letrozole. Endpoints; primary: local PFS; secondary: overall response rate (ORR), clinical benefit rate (CBR), safety. Results: Of all 820 pts treated with RIB + ET, 484 (59%) had visceral mets (ML-2 197/334; ML-3 137/238; ML-7 150/248); of all 710 pts treated with PBO + ET, 416 (59%) had visceral mets (ML-2 196/334; ML-3 77/129; ML-7 143/247). Median PFS was prolonged for RIB vs PBO in pts with and without visceral mets (Table). ORR and CBR were also higher for RIB vs PBO in pts with and without visceral mets. The most common (≥10% of pts in any arm) Grade [G] 3 and 4 adverse events (AEs) for each trial are shown in the table; no G4 AEs occurred in ≥10% of pts in ML-3. Visceral metsNo visceral metsML-2 Median PFS (RIB/PBO), months (95% CI)24.9 (22.2–30.9)/13.4 (12.7–16.5)25.3 (22.2–NR)/18.2 (15.0–24.6)Hazard ratio (95% CI)0.538 (0.408–0.709)0.634 (0.448–0.897) ORR (RIB/PBO),* %48/3735/17 CBR (RIB/PBO),† %79/7282/75 Most common (≥10% in any arm) G3 AEs (RIB/PBO), %Neutropenia56/147/1Leukopenia19/121/<1Hypertension11/1115/15 Most common (≥10% in any arm) G4 AEs (RIB/PBO), %Neutropenia10/09/0 ML-3 Median PFS (RIB/PBO), months (95% CI)NR (19.1–NR)/16.5 (9.0–NR)NR (NR–NR)/21.9 (14.8–NR)Hazard ratio (95% CI)0.610 (0.403–0.926)0.521 (0.295–0.921) ORR (RIB/PBO),* %46/2931/21 CBR (RIB/PBO),† %74/6075/81 Most common (≥10% in any arm) G3 AEs (RIB/PBO), %Neutropenia50/045/0Leukopenia12/010/0Increased ALT6/012/0 ML-7 Median PFS (RIB/PBO), months (95% CI)23.8 (14.8–NR)/10.4 (7.2–12.9)27.5 (NR–NR)/19.3 (16.5–NR)Hazard ratio (95% CI)0.507 (0.367–0.700)0.609 (0.377–0.984) ORR (RIB/PBO),* %45/3630/19 CBR (RIB/PBO),† %79/5783/81 Most common (≥10% in any arm) G3 AEs (RIB/PBO), %Neutropenia54/356/4Leukopenia14/116/1 Most common (≥10% in any arm) G4 AEs (RIB/PBO), %Neutropenia11/<19/0CI, confidence interval; NR, not reached. *ORR = complete response + partial response; †CBR = complete response + partial response + (stable disease + non-complete response/non-progressive disease ≥24 weeks). Conclusions: Although the presence of visceral mets is associated with a poorer prognosis, RIB + ET is an effective and well-tolerated treatment option for pts with HR+, HER2– ABC irrespective of the presence of visceral mets. Citation Format: Yardley DA, Chan A, Nusch A, Sonke GS, Yap Y-S, Bachelot T, Esteva FJ, Slamon DJ, Burris HA, Gaur A, Kong O, Diaz-Padilla I, Rodriguez Lorenc K, Wheatley-Price P. Ribociclib + endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: Subgroup analysis of phase III MONALEESA trials [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-07.
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