Palbociclib versus abemaciclib in HR+/HER2-advanced breast cancer: an indirect comparison of patient-reported end points

被引：13

作者：

Law, Ernest ^{[1
]}

Gavanji, Roya ^{[2
]}

Walsh, Sarah ^{[3
]}

Haltner, Anja ^{[3
]}

McTavish, Rebecca ^{[2
]}

Cameron, Chris ^{[3
]}

机构：

[1] Pfizer, New York, NY 10017 USA

[2] EVERSANA, Burlington, ON L7N 3H8, Canada

[3] EVERSANA, Sydney, NS B1P 1C6, Canada

来源：

JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH | 2021年 / 11卷 / 02期

关键词：

abemaciclib; advanced breast cancer; health-related quality of life; HER2-negative; hormone receptor-positive; indirect treatment comparison; matching-adjusted indirect comparison; palbociclib; patient-reported outcomes; quality of life; QUALITY-OF-LIFE; MONARCH; 2; ABEMACICLIB; PLUS FULVESTRANT; COMBINATION; GUIDELINES; OUTCOMES; WOMEN; CARE;

D O I：

10.2217/cer-2021-0221

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Aim: To assess the relative impact of palbociclib plus fulvestrant (PAL + FUL) and abemaciclib plus fulvestrant (ABEM + FUL) on patient-reported outcomes in patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. Patients & methods: Anchored matching-adjusted indirect comparisons were conducted using individual patient data from PALOMA-3 (PAL + FUL) and summary-level data from MONARCH-2 (ABEM + FUL). Outcomes included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) and its breast cancer-specific module (QLQ-BR23). Results: Significantly different changes from baseline favoring PAL + FUL compared with ABEM + FUL were observed in global quality of life (6.95 [95% CI: 2.19-11.71]; p = 0.004) and several functional/symptom scales, including emotional functioning, nausea/vomiting, appetite loss, diarrhea and systemic therapy side effects. Conclusion: PAL + FUL was associated with more favorable patient-reported outcomes than ABEM + FUL in patients with HR+/HER2- advanced breast cancer.

引用

页码：109 / 120

页数：12

共 34 条

[1] Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. [J].

Basch, Ethan M. ;

Deal, Allison Mary ;

Dueck, Amylou C. ;

Bennett, Antonia Vickery ;

Atkinson, Thomas Michael ;

Scher, Howard I. ;

Kris, Mark G. ;

Hudis, Clifford A. ;

Sabbatini, Paul ;

Dulko, Dorothy ;

Rogak, Lauren J. ;

Barz, Allison Emily ;

Schrag, Deborah .

JOURNAL OF CLINICAL ONCOLOGY, 2017, 35 (18)

[2] The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials [J].

Bucher, HC ;

Guyatt, GH ;

Griffith, LE ;

Walter, SD .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 1997, 50 (06) :683-691

[3] 3rd ESO-ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3) [J].

Cardoso, F. ;

Costa, A. ;

Senkus, E. ;

Aapro, M. ;

Andre, F. ;

Barrios, C. H. ;

Bergh, J. ;

Bhattacharyya, G. ;

Biganzoli, L. ;

Cardoso, M. J. ;

Carey, L. ;

Corneliussen-James, D. ;

Curigliano, G. ;

Dieras, V. ;

El Saghir, N. ;

Eniu, A. ;

Fallowfield, L. ;

Fenech, D. ;

Francis, P. ;

Gelmon, K. ;

Gennari, A. ;

Harbeck, N. ;

Hudis, C. ;

Kaufman, B. ;

Krop, I. ;

Mayer, M. ;

Meijer, H. ;

Mertz, S. ;

Ohno, S. ;

Pagani, O. ;

Papadopoulos, E. ;

Peccatori, F. ;

Pernault-Llorca, F. ;

Piccart, M. J. ;

Pierga, J. Y. ;

Rugo, H. ;

Shockney, L. ;

Sledge, G. ;

Swain, S. ;

Thomssen, C. ;

Tutt, A. ;

Vorobiof, D. ;

Xu, B. ;

Norton, L. ;

Winer, E. .

BREAST, 2017, 31 :244-259

[4] ESMO-Magnitude of Clinical Benefit Scale version 1.1 [J].

Cherny, N. I. ;

Dafni, U. ;

Bogaerts, J. ;

Latino, N. J. ;

Pentheroudakis, G. ;

Douillard, J. -Y. ;

Tabernero, J. ;

Zielinski, C. ;

Piccart, M. J. ;

de Vries, E. G. E. .

ANNALS OF ONCOLOGY, 2017, 28 (10) :2340-2366

[5] Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [J].

Cocks, K. ;

King, M. T. ;

Velikova, G. ;

de Castro, G., Jr. ;

St-James, M. Martyn ;

Fayers, P. M. ;

Brown, J. M. .

EUROPEAN JOURNAL OF CANCER, 2012, 48 (11) :1713-1721

[6] Overall survival (OS) with palbociclib (PAL) plus fulvestrant (FUL) in women with hormone receptor-positive (HR plus ), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Updated analyses from PALOMA-3. [J].

Cristofanilli, Massimo ;

Rugo, Hope S. ;

Im, Seock-Ah ;

Slamon, Dennis J. ;

Harbeck, Nadia ;

Bondarenko, Igor ;

Masuda, Norikazu ;

Colleoni, Marco ;

DeMichele, Angela ;

Iwata, Sherene Loi Hiroji ;

O'Leary, Ben ;

Bananis, Eustratios ;

Liu, Yuan ;

Huang, Xin ;

Kim, Sindy ;

Lechuga, Mariajose ;

Turner, Nicholas C. .

JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (15)

[7] Combination versus sequential single agent chemotherapy for metastatic breast cancer [J].

Dear, Rachel F. ;

McGeechan, Kevin ;

Jenkins, Marisa C. ;

Barratt, Alexandra ;

Tattersall, Martin H. N. ;

Wilcken, Nicholas .

COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2013, (12)

[8] Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer [J].

Denis, Fabrice ;

Basch, Ethan ;

Septans, Anne-Lise ;

Bennouna, Jaafar ;

Urban, Thierry ;

Dueck, Amylou C. ;

Letellier, Christophe .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019, 321 (03) :306-307

[9] Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study [J].

Fasching, Peter A. ;

Beck, J. Thaddeus ;

Chan, Arlene ;

De Laurentiis, Michele ;

Esteva, Francisco J. ;

Jerusalem, Guy ;

Neven, Patrick ;

Pivot, Xavier ;

Bianchi, Giulia V. ;

Martin, Miguel ;

Chandiwana, David ;

Lanoue, Brad ;

Ridol, Antonia ;

Wang, Yingbo ;

Lorenc, Karen Rodriguez ;

Nusch, Arnd .

BREAST, 2020, 54 :148-154

[10] Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial [J].

Harbeck, N. ;

Iyer, S. ;

Turner, N. ;

Cristofanilli, M. ;

Ro, J. ;

Andre, F. ;

Loi, S. ;

Verma, S. ;

Iwata, H. ;

Bhattacharyya, H. ;

Theall, K. Puyana ;

Bartlett, C. H. ;

Loibl, S. .

ANNALS OF ONCOLOGY, 2016, 27 (06) :1047-1054

← 1 2 3 4 →