Systematic literature review of clinical trials of endocrine therapies for premenopausal women with metastatic HR+ HER2− breast cancer
2019; Wiley; Volume: 25; Issue: 5 Linguagem: Inglês
10.1111/tbj.13345
ISSN1524-4741
AutoresOscar Patterson‐Lomba, Anand A. Dalal, Rajeev Ayyagari, Xinyue Liu, Eni Dervishi, Emma Platt, David Chandiwana, Joyce O’Shaughnessy,
Tópico(s)Breast Cancer Treatment Studies
ResumoThe Breast JournalVolume 25, Issue 5 p. 880-888 ORIGINAL ARTICLEOpen Access Systematic literature review of clinical trials of endocrine therapies for premenopausal women with metastatic HR+ HER2− breast cancer Oscar Patterson-Lomba PhD, Oscar Patterson-Lomba PhD Analysis Group, Inc., Boston, MassachusettsSearch for more papers by this authorAnand A. Dalal PhD, MBA, Anand A. Dalal PhD, MBA Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorRajeev Ayyagari PhD, Corresponding Author Rajeev Ayyagari PhD Rajeev.Ayyagari@analysisgroup.com orcid.org/0000-0003-0870-2309 Analysis Group, Inc., Boston, Massachusetts Correspondence Rajeev Ayyagari, Analysis Group, Inc., 111 Huntington Avenue, 14th Floor, Boston, MA 02199. Email: Rajeev.Ayyagari@analysisgroup.comSearch for more papers by this authorOlivia Liu MSc, Olivia Liu MSc Analysis Group, Inc., New York, New YorkSearch for more papers by this authorEni Dervishi BA, Eni Dervishi BA Analysis Group, Inc., Boston, MassachusettsSearch for more papers by this authorEmma Platt PharmD, Emma Platt PharmD Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorDavid Chandiwana MSc, David Chandiwana MSc Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorJoyce A. O'Shaughnessy MD, Joyce A. O'Shaughnessy MD Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology, Dallas, TexasSearch for more papers by this author Oscar Patterson-Lomba PhD, Oscar Patterson-Lomba PhD Analysis Group, Inc., Boston, MassachusettsSearch for more papers by this authorAnand A. Dalal PhD, MBA, Anand A. Dalal PhD, MBA Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorRajeev Ayyagari PhD, Corresponding Author Rajeev Ayyagari PhD Rajeev.Ayyagari@analysisgroup.com orcid.org/0000-0003-0870-2309 Analysis Group, Inc., Boston, Massachusetts Correspondence Rajeev Ayyagari, Analysis Group, Inc., 111 Huntington Avenue, 14th Floor, Boston, MA 02199. Email: Rajeev.Ayyagari@analysisgroup.comSearch for more papers by this authorOlivia Liu MSc, Olivia Liu MSc Analysis Group, Inc., New York, New YorkSearch for more papers by this authorEni Dervishi BA, Eni Dervishi BA Analysis Group, Inc., Boston, MassachusettsSearch for more papers by this authorEmma Platt PharmD, Emma Platt PharmD Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorDavid Chandiwana MSc, David Chandiwana MSc Novartis Pharmaceuticals Corporation, East Hanover, New JerseySearch for more papers by this authorJoyce A. O'Shaughnessy MD, Joyce A. O'Shaughnessy MD Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology, Dallas, TexasSearch for more papers by this author First published: 09 July 2019 https://doi.org/10.1111/tbj.13345Citations: 2 Funding information Sponsorship for this study was provided by Novartis Pharmaceuticals Corporation. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Several endocrine-based therapies have recently been evaluated as treatments for premenopausal women with hormone-receptor-positive/human-epidermal-growth-factor-receptor 2 negative (HR+/HER2−) metastatic breast cancer (mBC). We conducted a systematic review and assessed the feasibility of an indirect treatment comparison (ITC) to characterize the comparative efficacy of endocrine-based therapies in this setting. A systematic literature review (SLR) of Medline, EMBASE, Cochrane Library and key conferences was performed to identify randomized clinical trials (RCTs) satisfying the following criteria: (a) included pre/perimenopausal women with HR+/HER2− mBC, (b) included endocrine-based therapies, (c) reported efficacy, safety, or quality of life outcomes, and (d) was published in 2007 or later (when HER2 testing was standardized). The clinical and methodological similarities across trials were assessed to evaluate the feasibility of an ITC. Four RCTs (PALOMA-3, MONARCH-2, KCSG BR10-04 and MONALEESA-7) and eight regimens (palbociclib + fulvestrant + goserelin, fulvestrant + goserelin, abemaciclib + fulvestrant + gonadotropin-releasing hormone agonist [GnRHa], fulvestrant + GnRHa, anastrozole + goserelin, goserelin, ribociclib + NSAI/tamoxifen + goserelin and NSAI/tamoxifen + goserelin) were selected. MONALEESA-7 was the only phase 3 trial investigating endocrine-based therapies as first-line in only pre/perimenopausal women with HR+/HER2− mBC; the other three trials focused on the ET-failure setting and their pre/perimenopausal populations were relatively small. ITCs were methodologically unfeasible due to critical differences in treatment settings and lack of common comparators across trials. Therefore, we were not able to characterize the relative efficacy of the different endocrine-based therapies available in the premenopausal HR+/HER2− mBC setting. This systematic review provides a comprehensive assessment of the available trial evidence on the efficacy and safety of endocrine-based therapies for premenopausal women with HR+/HER2− mBC. Only four trials have reported relevant data in this setting, and MONALEESA-7 is currently the only trial focused on premenopausal HR+ HER2− mBC in the first-line setting. 1 INTRODUCTION Breast cancer (BC) is the most common cancer among women in the United States, with approximately 252 710 new cases and 40 610 deaths in 2017.1 Hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2−) is the most common BC subtype, accounting for approximately 70% of BC cases.2 More than 90% of BC cases are detected in early stage (stage I-II), with approximately one-quarter diagnosed in premenopausal women,3 although the majority of cases progress to advanced or metastatic disease.4 A recent study reported that about one third of de novo metastatic BC (mBC) cases were diagnosed in premenopausal women.5 Typically, younger women are diagnosed with BC less often than older women. For instance, 20% of all breast cancers in the USA are diagnosed in women younger than 50 years,6 although in other regions, such as the Middle East and Latin America, the estimated percentages are almost 50%.7, 8 However, BC in premenopausal women tend to be more often diagnosed in a higher stage compared to BC in postmenopausal women,9, 10 partly due to the lack of routine screening mammography guidelines for younger women. Also, younger women tend to have tumors with a more aggressive phenotype and poor prognostic features; recent studies have reported that women 2 NR NR 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Missing NR NR NR NR 0 (0.0) 0 (0.0) 0 (0.0) 3 (0.9) 3 (0.9) Prior therapy, N (%) Endocrine therapy 72 (100.0) 36 (100.0) 72 (100) 42 (100) NR NR NR 127 (37.9)e 141 (41.8)e Chemotherapy 23 (31.9)f 12 (33.3)f NR NR 10 (22.7) 10 (21.3) 12 (25.5) 185 (55.2)g 185 (54.8)g Cancer stage, N (%) NR NR Locally advanced NR NR 0 (0.0)c 0 (0.0)c 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.3) 1 (0.3) Metastatic NR NR 72 (100.0)c 42 (100.0)c 44 (100.0) 47 (100.0) 47 (100.0) 334 (99.7) 336 (99.7) Abbreviation(s): ECOG, Eastern Cooperative Oncology Group; GnRHa, gonadotropin-releasing hormone agonist (eg, goserelin); NR, not reported; NSAI, nonsteroidal aromatase inhibitor. a Baseline characteristics are for the entire trial population. Trials with * have 100% pre- or peri-menopausal population or report baseline characteristics for the pre- or peri-menopausal population. b Age was reported as number and percentage for the following age groups: ≤40, 40-50, and >50 y old. c The data has been extracted from the 2018 ASCO Annual Meeting Presentation. d Other includes Black, Native American and etc when these categories have not been reported separately. e Prior (neo) adjuvant endocrine therapy. f Previous chemotherapy in metastatic setting. Subjects are counted for each treatment of metastatic disease (± neoadjuvant) received. g Calculated as the sum of chemotherapy for (neo) adjuvant only and advanced disease. Key outcomes from all the selected trials are shown in Table 3, although several of these outcomes were not reported for some of the trials. PFS HR for the premenopausal population was reported in PALOMA-3 (palbociclib vs placebo arm: 0.50 [0.29-0.87]), MONARCH-2 (abemaciclib vs placebo arm: 0.45, [0.26-0.75]), KCSG BR 10-04 (fulvestrant + goserelin vs goserelin: 0.61 [0.37-1.00]; anastrozole + goserelin vs goserelin: 0.98 [0.62-1.55]) and MONALEESA-7 (ribociclib vs placebo arm: 0.55 [0.44-0.69]). Table 3. Outcomes in the premenopausal populations Characteristicsa PALOMA-3 MONARCH-2 KCSG BR10-04 MONALEESA-7 Palbociclib + fulvestrant + goserelin Placebo + fulvestrant + goserelin Abemaciclib + fulvestrant + GnRHa Placebo + fulvestrant + GnRHa Fulvestrant + goserelin Anastrozole + goserelin Goserelin alone Ribociclib + NSAI/tamoxifen + goserelin Placebo + NSAI/tamoxifen + goserelin Trial phase III III II III Sample size, N 72 36 72 42 44 47 47 335 337 PFS hazard ratio 0.50 NA 0.45 NA 0.61 0.98 NA 0.55 NA 95% CI (0.29-0.87) NA (0.26-0.75) NA (0.37-1.00) (0.62-1.55) NA (0.44-0.69) NA Median PFS (mo) 9.5 5.6 Not reached 10.5 NR NR NR 23.8 13.0 95% CI NR NR NR NR NR NR NR (19.2-not reached) (11.0-16.4) TTP hazard ratio NR NR NR NR NR NR NR NR NR 95% CI NR NR NR NR NR NR NR NR NR Median TTP (mo) NR NR NR NR 16.3 14.5 13.5 NR NR 95% CI NR NR NR NR (7.5-25.1) (11.0-18.0) (10.3-16.8) NR NR OS hazard ratio NR NR NR NR 0.60 0.52 NR 0.92 NA 95% CI NR NR NR NR (0.28-1.32) (0.23-1.19) NR (0.6-1.4) NA Median OS (mo) NR NR NR NR Not reachedb Not reachedb 53.5 Not Reachedb 29.4 95% CI NR NR NR NR NR NR NR NR (28.2, NE) ORR, N (%) 18 (25.0) 4 (11.1) 31 (43.1)d 8 (19.0)d NRc NRc NRc 137 (40.9) 100 (29.7) CBR, N (%) 50 (69.4) 16 (44.4) 56 (77.8)d 29 (69.0)d NRc NRc NRc 265 (79.1) 235 (69.7) Overall AEs, N (%) 71 (98.6) 35 (97.2) 70 (98.6) 40 (95.2) NR NR NR 329 (98.2) 317 (94.1) Overall SAEs, N (%) 10 (14.1) 7 (19.4) 8 (11.3) 2 (4.8) NR NR NR 60 (17.9) 39 (11.6) Discontinuation due to AE, N (%) 4 (5.6) 0 (0.0) 4 (5.6) 0 (0.0) NR NR NR 21 (6.3) 12 (3.6) All-cause discontinuation, N (%) NR NR NR NR NR NR NR 161 (48.1) 216 (64.1) EORTC QLQ-C30 hazard ratio NR NR NR NR NR NR NR 0.7e NAe EORTC QLQ-B23 hazard ratio NR NR NR NR NR NR NR 0.68e NAe FACT-B hazard ratio NR NR NR NR NR NR NR NR NR EQ-5D NR NR NR NR NR NR NR 0.68e NAe Abbreviation(s): AE, adverse event; CBR, clinical benefit rate; GnRHa, gonadotropin-releasing hormone agonist (eg, goserelin); NA, not applicable; NE, not estimable; NR, not reported; NSAI, nonsteroidal aromatase inhibitor; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; SAE, serious AE; TTP, time to progression. a Sample size and outcomes correspond to the pre- or peri-menopausal population. b Median OS was not reached. c The poster has information for partial response and stable response, but not for complete response. Therefore we cannot derive ORR and CBR values. d The reported ORR and CBR values pertain to the ITT population. e There was a delay in the time to definitive 10% deterioration for the global health status/quality of life scale in the ribociclib arm vs the placebo arm. PALOMA-3, MONARCH-2 and MONALEESA-7 reported median PFS, while KCSG BR 10-04 reported TTP. The median time to progression or death is longer in MONALEESA-7 compared to the other three trials, partly due to the former trial being in the first-line setting. Overall response rate (ORR) was larger in MONARCH-2 compared to MONALEESA-7 and PALOMA-3. Only MONALEESA-7 reported quality of life outcomes in the premenopausal population. Although there were differences between the PALOMA-3 and MONARCH-2 trials (eg, reference arms were slightly different [in MONARCH-2 it was not specified that goserelin was the only GnRHa used], and patients had different prior treatment history [more patients in MONARCH-2 progressed within 12 months of adjuvant ET]), a naïve comparison of the PFS HR between these two trials indicates that abemaciclib + fulvestrant + GnRHa (HR = 0.45) is associated with a lower hazard of progression or death than palbociclib + fulvestrant + goserelin (HR = 0.50). However, due to the small sample size limitation, the confidence intervals around these estimates are large and overlapping. 3.2 Quality assessment Quality assessment of the identified RCTs were based on the criteria described in Table 4, adapted from the "Systematic reviews: CRD's guidance for undertaking reviews in health care" (University of York Centre for Reviews and Dissemination).26 The included trials were all well-conducted and the risk of bias was low to moderate, with concealment of allocation (with the exception of KCSG BR10-04). Table 4. Quality assessment Trial no. (acronym) PALOMA-3 MONARCH-2 KCSG BR10-04 MONALEESA-7 Was randomization carried out appropriately? Yes Yes Not clear Yes Was the concealment of treatment allocation adequate? Yes Yes N/Aa Yes Were the groups similar at the outset of the study in terms of prognostic factors? Yes Yes Yes Yes Were the care providers, participants, and outcome assessors blind to treatment allocation? Yes Yes N/Aa Yes Were there any unexpected imbalances in drop-outs between groups? No Yes Not clear No Is there any evidence to suggest that the authors measured more outcomes than they reported? No No No No Did the analysis include an intention–to–treat analysis? If so, was this appropriate and were appropriate methods used to account for missing data Yes Yes Not clear Yes Abbreviation(s): N/A, not applicable. a KCSG BR10-04 is an open label trial. 3.3 Indirect treatment comparison Figure 2 shows the disconnected network of the four identified trials, corresponding to the PFS HR outcome (the only outcome reported for all trials). In order to form a fully connected network, strong clinical assumptions are needed, such as "pooling" endocrine-based therapies (ie, assume that the clinical efficacies of the comparator arms in PALOMA-3 [fulvestrant + goserelin], MONARCH-2 [fulvestrant + GnRHa] and MONALEESA-7 [NSAI/tamoxifen + goserelin] are all similar in terms of PFS). Moreover, MONALEESA 7 is in the first-line (ET-naïve) setting, while all other studies are in the ET-failure setting. Hence, to be able to compare the ribociclib arm with the rest of the therapies, it would have to be assumed that the PFS HRs are similar in the first-line and second line settings. This difference in treatment settings also limits the validity of an indirect comparison via a matching-adjusted indirect comparison approach.27 Figure 2Open in figure viewerPowerPoint Evidence networks for PFS hazard ratio. Abbreviations: Abe, abemaciclib; Ana, anastrozole; ET, endocrine therapy; Ful, fulvestrant; GnRHa, gonadotropin-releasing hormone agonist (eg, goserelin); Gos, goserelin; NSAI, non-steroidal aromatase inhibitors; Pal, palbociclib; PFS, progression free survival; Ribo, ribociclib; Tam, tamoxifen 4 DISCUSSION The treatment landscape for premenopausal women with HR+/HER2− mBC is rapidly changing as treatments previously approved in the postmenopausal setting are now being also assessed in premenopausal women. Hence, there is a need for patients, clinicians, and payers to assess the relative benefits and risks of the emerging and currently available endocrine-based therapies in the premenopausal setting. To that end, we conducted a SLR and assessed the feasibility of an indirect comparison of the available evidence. To our knowledge, this is the first SLR in this clinical and therapeutic setting. The literature search indicated that only four RCTs (PALOMA-3, MONARCH-2, KCSG BR10-04, and MONALEESA-7) have assessed the effectiveness of endocrine-based therapies in premenopausal women with HR+/HER2− mBC. MONALEESA-7 is the first phase 3 trial investigating a CDK4/6 inhibitor (ribociclib) as first-line endocrine-based therapy in only pre/perimenopausal women with mBC, whereas the other three trials focused on the ET-failure setting. As MONALEESA-7 focused solely on premenopausal women, this trial had a large population size, while the other three trials featured relatively small premenopausal patient populations and as a result their power to detect clinically relevant treatment effects may be limited. Notwithstanding, the PALOMA-3, MONARCH-2, and MONALEESA-7 trials consistently indicated that combining a CDK4/6 inhibitor with an endocrine monotherapy (fulvestrant, tamoxifen or NSAI) and a GnRHa (eg, goserelin) led to improvements in PFS and ORR in premenopausal women with HR+/HER2− mBC. In assessing the feasibility of a formal ITC, it was determined that the treatments in these trials do not form a connected network, unless strong clinical assumptions are granted. ITCs via an NMA were deemed methodologically unfeasible given the critical differences in treatment settings (MONALEESA 7 is in the first-line (ET-naïve) setting, while all other studies are in the ET-failure setting), in addition to the disconnected geometry of the evidence network. The unfeasibility of this indirect comparison is also in part due to the inconsistency in the endocrine therapy partner (goserelin vs any GnRHa), which indicates that some trials (eg, MONARCH-2) may have not been designed primarily to show a benefit of their investigational treatment in premenopausal women. The PALOMA-3 and MONARCH-2 trials did not focus exclusively on the premenopausal population and their PFS results correspond to subgroup analysis that may be underpowered (in the case of MONARCH-2, the subgroup analyses in the premenopausal population was not pre-specified in the study protocol). One of the limitations of the present study is that, due to the lack of clinical trial data available for the premenopausal HR+/HER2− mBC population, we could not perform an ITC of all the therapies in the studies identified in the literature search. Hence, it was not feasible to assess the relative efficacy of the different treatments available in this setting. Additionally, there were gaps in the reporting of patient characteristics or outcomes for the premenopausal population in some of the identified studies. 5 CONCLUSIONS To conclude, this systematic literature evaluation provides a comprehensive review of the available clinical trial evidence on the efficacy and safety of ET as treatments for premenopausal women with HR+/HER2− mBC. The search demonstrated the paucity of RCTs focusing on premenopausal HR+ HER2− mBC, with only four trials having reported relevant data in this setting. MONALEESA-7 is currently the only phase 3 trial focused on premenopausal HR+ HER2− mBC in the first-line setting. Efficacy results from the selected trials indicated that combining a CDK4/6 inhibitor with an endocrine monotherapy and a GnRHa led to improvements in PFS and ORR in premenopausal women with HR+/HER2− mBC in the first-line and ET-failure settings. CONFLICT OF INTEREST OP-L, RA, OL, and ED are employees of Analysis Group Inc, which has received consultancy fees from Novartis. AAD, EP, and DC are employees of Novartis and may own stock/stock options. JAO received consultancy fees from Novartis. REFERENCES 1 NCI. National Cancer Institute. SEER stat fact sheets: female breast cancer. https://seer.cancer.gov/statfacts/html/breast.html. Accessed April 11, 2018. 2Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014; 106(5). 3Kadakia KC, Henry NL. Adjuvant endocrine therapy in premenopausal women with breast cancer. Clin Adv Hematol Oncol. 2015; 13(10): 663- 672. 4 Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005; 365(9472): 1687- 1717. 5Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010; 21(11): 2169- 2174. 6Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017; 67(1): 7- 30. 7El Saghir NS, Khalil MK, Eid T, et al. Trends in epidemiology and management of breast cancer in developing Arab countries: a literature and registry analysis. Int J Surg. 2007; 5(4): 225- 233. 8Rodriguez-Cuevas S, Macias CG, Franceschi D, Labastida S. Breast carcinoma presents a decade earlier in Mexican women than in women in the United States or European countries. Cancer. 2001; 91(4): 863- 868. 9Pfeiler G. Systemic treatment in premenopausal patients with breast cancer. Breast Care (Basel). 2015; 10(5): 305- 306. 10Gnerlich JL, Deshpande AD, Jeffe DB, Sweet A, White N, Margenthaler JA. Elevated breast cancer mortality in women younger than age 40 years compared with older women is attributed to poorer survival in early-stage disease. J Am Coll Surg. 2009; 208(3): 341- 347. 11Partridge AH, Hughes ME, Warner ET, et al. Subtype-dependent relationship between young age at diagnosis and breast cancer survival. J Clin Oncol. 2016; 34(27): 3308- 3314. 12 National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines) Breast Cancer Version I. 2017. www.nccn.org. Accessed June 26, 2018. 13 Breastcancer.org. Who gets chemotherapy? http://www.breastcancer.org/treatment/chemotherapy/who_gets_it. Accessed November 2, 2017. 14Gonzalez-Angulo AM, Morales-Vasquez F, Hortobagyi GN. Overview of resistance to systemic therapy in patients with breast cancer. https://www.ncbi.nlm.nih.gov/books/NBK6306/. Accessed June 26, 2018. 15Loibl S, Turner NC, Ro J, et al. Palbociclib combined with fulvestrant in premenopausal women with advanced breast cancer and prior progression on endocrine therapy: PALOMA-3 results. Oncologist. 2017; 22(9): 1028- 1038. 16Neven P, Rugo HS, Tolaney SM, et al. Abemaciclib for pre/perimenopausal women with HR+, HER− advanced breast cancer. J Clin Oncol. 2018; 36(15_suppl): 1002- 1002. 17Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018; 19(7): 904- 915. 18Ayyagari R, Tang D, Patterson-Lomba O, et al. Progression-free survival with first-line endocrine-based therapies among postmenopausal women with HR+/HER2− metastatic breast cancer: a network meta-analysis. Clin Ther. 2018; 40(4): 628- 639.e3. 19Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007; 131(1): 18- 43. 20Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009; 6(7): e1000097. 21 Cochrane handbook for systematic reviews of interventions. http://handbook.cochrane.org/chapter_8/table_8_5_a_the_cochrane_collaborations_tool_for_assessing.htm. Accessed June 26, 2018. 22Turner NC, Ro J, André F, et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 2015; 373(3): 209- 219. 23Sledge Jr GW, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women With HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017; 35(25): 2875- 2884. 24Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016; 17(4): 425- 439. 25Kim J-Y, Im S-A, Jung KH, et al. A phase II, randomized, open-label 3-arm clinical trial of fulvestrant (F) plus goserelin (G) versus anastrozole (A) plus goserelin (G) versus goserelin (G) alone for hormone receptor (HR) positive, tamoxifen (T) pretreated premenopausal women with recurrent or metastatic breast cance r(MBC) (KCSG BR10-04). J Clin Oncol. 2017; 35(15_suppl): 1041- 1041. 26 Centre for Reviews and Dissemination. CRD's guidance for undertaking reviews in health care. https://www.york.ac.uk/media/crd/Systematic_Reviews.pdf. Accessed June 26, 2018. 27Signorovitch JE, Wu EQ, Yu AP, et al. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010; 28(10): 935- 945. Citing Literature Volume25, Issue5September/October 2019Pages 880-888 FiguresReferencesRelatedInformation
Referência(s)