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Efficacy and safety of anticancer drug combinations: a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds

, , , & ORCID Icon
Article: 1710052 | Received 01 Sep 2019, Accepted 29 Nov 2019, Published online: 13 Jan 2020

References

  • Carmo-Pereira J, Costa FO, Henriques E. Single-drug vs combination cytotoxic chemotherapy in advanced breast cancer: a randomized study. Eur J Cancer. 1980;16:1621–12. doi:10.1016/0014-2964(80)90037-7.
  • Biganzoli L, Minisini A, Aapro M, Di Leo A. Chemotherapy for metastatic breast cancer. Curr Opin Obstet Gynecol. 2004;16:37–41. doi:10.1097/00001703-200402000-00008.
  • Vale, C. L., Tierney, J., Bull, S. J., & Symonds, P. R. Chemotherapy for advanced, recurrent or metastatic endometrial carcinoma. Cochrane Database Syst Rev. 2012. 15;(8) CD003915.
  • Zer A, Prince RM, Amir E, Abdul Razak AR. Multi-agent chemotherapy in advanced soft tissue sarcoma (STS) - A systematic review and meta-analysis. Cancer Treat Rev. 2018;63:71–78. doi:10.1016/j.ctrv.2017.12.003.
  • Hu Q, Sun W, Wang C, Gu Z. Recent advances of cocktail chemotherapy by combination drug delivery systems. Adv Drug Deliv Rev. 2016;98:19–34. doi:10.1016/j.addr.2015.10.022.
  • de la Torre BG, Albericio F. The pharmaceutical industry in 2017. An analysis of FDA drug approvals from the perspective of molecules. Molecules. 2018;23:533. doi:10.3390/molecules23030533.
  • Druker BJ, David A. Karnofsky award lecture. Imatinib as a paradigm of targeted therapies. J Clin Oncol. 2003;21:239s–245s. doi:10.1200/JCO.2003.10.589.
  • Jardim DL, Schwaederle M, Wei C, Lee JJ, Hong DS, Eggermont AM, Schilsky RL, Mendelsohn J, Lazar V, KurzrockR. Impact of a biomarker-based strategy on oncology drug development: a meta-analysis of clinical trials leading to FDA approval. J Natl Cancer Inst. 2015;107:djv253.
  • Fang L, Lonsdorf AS, Hwang ST. Immunotherapy for advanced melanoma. J Invest Dermatol. 2008;128:2596–2605. doi:10.1038/jid.2008.101.
  • Liu S, Nikanjam M, Kurzrock R. Dosing de novo combinations of two targeted drugs: towards a customized precision medicine approach to advanced cancers. Oncotarget. 2016;7:11310–11320. doi:10.18632/oncotarget.7023.
  • Nikanjam M, Liu S, Kurzrock R. Dosing targeted and cytotoxic two-drug combinations: lessons learned from analysis of 24,326 patients reported 2010 through 2013. Int J Cancer. 2016;139:2135–2141. doi:10.1002/ijc.v139.9.
  • Nikanjam M, Liu S, Yang J, Kurzrock R. Dosing three-drug combinations that include targeted anti-cancer agents: analysis of 37,763 patients. Oncologist. 2017;22:576–584. doi:10.1634/theoncologist.2016-0357.
  • Fiteni F, Bonnetain F. Surrogate end points for overall survival in breast cancer trials: A review. Breast. 2016;29:44–48. doi:10.1016/j.breast.2016.06.005.
  • Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13(Suppl 2):19–21. doi:10.1634/theoncologist.13-S2-19.
  • Lebwohl D, Kay A, Berg W, Baladi JF, Zheng J. Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development. Cancer J. 2009;15:386–394. doi:10.1097/PPO.0b013e3181b9c5ec.
  • Finn RS, Martin M, Rugo HS, Jones S, Im S-A, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375:1925–1936. doi:10.1056/NEJMoa1607303.
  • Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29:1541–1547. doi:10.1093/annonc/mdy155.
  • Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen S-C, Manso L, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638–3646. doi:10.1200/JCO.2017.75.6155.
  • Tanguy ML, Cabel L, Berger F, Pierga J-Y, Savignoni A, Bidard F-C. Cdk4/6 inhibitors and overall survival: power of first-line trials in metastatic breast cancer. NPJ Breast Cancer. 2018;4:14. doi:10.1038/s41523-018-0068-4.
  • Wei Y, Royston P, Tierney JF, Parmar MKB. Meta-analysis of time-to-event outcomes from randomized trials using restricted mean survival time: application to individual participant data. Stat Med. 2015;34:2881–2898. doi:10.1002/sim.v34.21.
  • Bayat Mokhtari R, Homayouni TS, Baluch N, Morgatskaya E, Kumar S, Das B, Yeger H. Combination therapy in combating cancer. Oncotarget. 2017;8:38022–38043. doi:10.18632/oncotarget.16723.
  • Zhao B, Pritchard JR, Lauffenburger DA, Hemann MT. Addressing genetic tumor heterogeneity through computationally predictive combination therapy. Cancer Discov. 2014;4:166–174. doi:10.1158/2159-8290.CD-13-0465.
  • Silberstein JL, Taylor MN, Antonarakis ES. Novel insights into molecular indicators of response and resistance to modern androgen-axis therapies in prostate cancer. Curr Urol Rep. 2016;17:29. doi:10.1007/s11934-016-0584-4.
  • Attarian S, Rahman N, Halmos B. Emerging uses of biomarkers in lung cancer management: molecular mechanisms of resistance. Ann Transl Med. 2017;5:377. doi:10.21037/atm.
  • Schwaederle M, Zhao M, Lee JJ, Eggermont AM, Schilsky RL, Mendelsohn J, Lazar V, Kurzrock R. Impact of precision medicine in diverse cancers: a meta-analysis of phase II clinical trials. J Clin Oncol. 2015;33:3817–3825. doi:10.1200/JCO.2015.61.5997.
  • Ottaiano A, Mollo E, Di Lorenzo G, Pisano C, Di Maio M, Barletta E, Pensabene M, Segati R, Bullian P, Nasti G, et al. Prospective clinical trials of biotherapies in solid tumors: a 5-year survey. Cancer Immunol Immunother. 2005;54:44–50. doi:10.1007/s00262-004-0567-z.
  • Nikanjam M, Patel H, Kurzrock R. Dosing immunotherapy combinations: analysis of 3,526 patients for toxicity and response patterns. Oncoimmunology. 2017;6:e1338997. doi:10.1080/2162402X.2017.1338997.
  • Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon R-A, Reed K, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013;369:122–133. doi:10.1056/NEJMoa1302369.
  • Long GV, Atkinson V, Cebon JS, Jameson MB, Fitzharris BM, McNeil CM, Hill AG, Ribas A, Atkins MB, Thompson JA, et al. Standard-dose pembrolizumab in combination with reduced-dose ipilimumab for patients with advanced melanoma (KEYNOTE-029): an open-label, phase 1b trial. Lancet Oncol. 2017;18:1202–1210. doi:10.1016/S1470-2045(17)30428-X.
  • Queirolo P, Spagnolo F. Atypical responses in patients with advanced melanoma, lung cancer, renal-cell carcinoma and other solid tumors treated with anti-PD-1 drugs: A systematic review. Cancer Treat Rev. 2017;59:71–78. doi:10.1016/j.ctrv.2017.07.002.
  • Lipson EJ, Sharfman WH, Drake CG, Wollner I, Taube JM, Anders RA, Xu H, Yao S, Pons A, Chen L, et al. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res. 2013;19:462–468. doi:10.1158/1078-0432.CCR-12-2625.
  • Kato S, Goodman A, Walavalkar V, Barkauskas DA, Sharabi A, Kurzrock R. Hyperprogressors after immunotherapy: analysis of genomic alterations associated with accelerated growth rate. Clin Cancer Res. 2017;23:4242–4250. doi:10.1158/1078-0432.CCR-16-3133.
  • Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria J-C, et al. Hyperprogressive disease is a new pattern of progression in cancer patients treated by anti-PD-1/PD-L1. Clin Cancer Res. 2017;23:1920–1928. doi:10.1158/1078-0432.CCR-16-1741.
  • Hoering A, Durie B, Wang H, Crowley J. End points and statistical considerations in immuno-oncology trials: impact on multiple myeloma. Future Oncol. 2017;13:1181–1193. doi:10.2217/fon-2016-0504.
  • Gyawali B, Hey S, Kesselheim AS. A comparison of response patterns for progression-free survival and overall survival following treatment for cancer with pd-1 inhibitors: A meta-analysis of correlation and differences in effect sizes. JAMA Network Open. 2018;1:e180416.
  • Tosi D, Laghzali Y, Vinches M, Alexandre M, Homicsko K, Fasolo A, Del Conte G, Durigova A, Hayaoui N, Gourgou S, et al. Clinical development strategies and outcomes in first-in-human trials of monoclonal antibodies. J Clin Oncol. 2015;33:2158–2165. doi:10.1200/JCO.2014.58.1082.
  • Jardim DL, Hess KR, Lorusso P, Kurzrock R, Hong DS. Predictive value of phase I trials for safety in later trials and final approved dose: analysis of 61 approved cancer drugs. Clin Cancer Res. 2014;20:281–288. doi:10.1158/1078-0432.CCR-13-2103.
  • Jardim DL, de Melo Gagliato D, Giles FJ, Kurzrock R. Analysis of drug development paradigms for immune checkpoint inhibitors. Clin Cancer Res. 2018;24:1785–1794. doi:10.1158/1078-0432.CCR-17-1970.
  • Emens LA, Middleton G. The interplay of immunotherapy and chemotherapy: harnessing potential synergies. Cancer Immunol Res. 2015;3:436–443. doi:10.1158/2326-6066.CIR-15-0064.
  • Palmer AC, Sorger PK. Combination cancer therapy can confer benefit via patient-to-patient variability without drug additivity or synergy. Cell. 2017;171:1678–1691 e13. doi:10.1016/j.cell.2017.11.009.
  • Motzer RJ, Barrios CH, Kim TM, Falcon S, Cosgriff T, Harker WG, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, et al. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014;32:2765–2772. doi:10.1200/JCO.2013.54.6911.
  • Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Loannidis J, Clarke M, Devereaux PJ, KleijnenJ, Moher D. The prisma statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanationand elaboration. Ann Intern Med. 2009;151:W65–94.
  • ASCO Meeting Library. 2018. https://meetinglibrary.asco.org.
  • Conferences ESMO. 2018. https://cslide.ctimeetingtech.com/library/esmo/home.
  • Viechtbauer W. Conducting meta-analyses in r with the metafor package. J Stat Softw. 2010;36(3):1-48. doi:10.18637/jss.v036.i03.
  • Knapp G, Hartung J. Improved tests for a random effects meta-regression with a single covariate. Stat Med. 2003;22:2693–2710.