Efficacy and safety of ramucirumab and docetaxel in previously treated patients with squamous cell lung cancer: a multicenter retrospective cohort study.
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Carcinoma, Squamous Cell
/ drug therapy
Docetaxel
Epithelial Cells
/ pathology
Humans
Lung Neoplasms
/ drug therapy
Retrospective Studies
Treatment Outcome
Ramucirumab
Non-small cell lung cancer
Ramucirumab
Squamous cell carcinoma
Treatment outcome
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
received:
18
12
2021
accepted:
05
01
2022
pubmed:
14
1
2022
medline:
18
5
2022
entrez:
13
1
2022
Statut:
ppublish
Résumé
Ramucirumab plus docetaxel (RAM/DOC) therapy is currently the standard for previously treated advanced non-small cell lung cancer (NSCLC), irrespective of histology. However, in the clinical trial, only the first-line platinum-based chemotherapy refractory patients were enrolled and the eligible criteria was strict to avoid hemoptysis, especially in squamous cell NSCLC (Sq). Thus, the efficacy and safety data on ramucirumab for Sq in real-world settings after immune checkpoint inhibitors monotherapy or combination therapy approved as novel first-line therapy is lacking. We retrospectively analyzed previously treated patients with advanced NSCLC who underwent RAM/DOC therapy at four institutions. Clinical data on the initiation of RAM/DOC were collected from medical records. Treatment outcomes were assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1. Incidence of pulmonary hemorrhage was assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Overall, 237 patients with NSCLC were included and 38 (16%) had squamous cell carcinoma. There were no significant differences in median progression-free survival and overall survival between Sq and non-Sq patients (5.8 months vs. 4.3 months, P = 0.0937; 15.2 months vs. 13.4 months, P = 0.714, respectively). Of all patients, 13 (5%) developed pulmonary hemorrhage. According to histological analysis, there was no significant difference in pulmonary hemorrhage proportion between Sq and non-Sq cohorts (2/38 vs. 11/199, respectively, P = 0.947). For previously treated patients with Sq, the efficacy and safety of RAM/DOC therapy were confirmed in a real-world setting and were similar to non-Sq.
Identifiants
pubmed: 35024985
doi: 10.1007/s10637-022-01214-w
pii: 10.1007/s10637-022-01214-w
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Docetaxel
15H5577CQD
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
634-642Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Siegel RL, Miller KD, Jemal A (2020) Cancer statistics, 2020. CA Cancer J Clin 70:7–30. https://doi.org/10.3322/caac.21590
doi: 10.3322/caac.21590
pubmed: 31912902
Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA (2008) Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc 83:584–594. https://doi.org/10.4065/83.5.584
doi: 10.4065/83.5.584
pubmed: 18452692
Barlesi F, Mazieres J, Merlio JP, Debieuvre D, Mosser J, Lena H, Ouafik L, Besse B, Rouquette I, Westeel V, Escande F, Monnet I, Lemoine A, Veillon R, Blons H, Audigier-Valette C, Bringuier PP, Lamy R, Beau-Faller M, Pujol JL, Sabourin JC, Penault-Llorca F, Denis MG, Lantuejoul S, Morin F, Tran Q, Missy P, Langlais A, Milleron B, Cadranel J, Soria JC, Zalcman G, Biomarkers France contributors (2016) Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet 387:1415–1426. https://doi.org/10.1016/S0140-6736(16)00004-0
Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O’Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR, KEYNOTE-024 Investigators (2016) Pembrolizumab versus chemotherapy for PD-L1–positive non–small-cell lung cancer. N Engl J Med 375:1823–1833. https://doi.org/10.1056/NEJMoa1606774
Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G, Jr., Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G, KEYNOTE-042 Investigators (2019) Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet 393:1819–1830. https://doi.org/10.1016/S0140-6736(18)32409-7
Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC, KEYNOTE-189 Investigators (2018) Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med 378:2078–2092. https://doi.org/10.1056/NEJMoa1801005
Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM, KEYNOTE-407 Investigators (2018) Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med 379:2040–2051. https://doi.org/10.1056/NEJMoa1810865
Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M, IMpower150 Study Group (2018) Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med 378:2288–2301. https://doi.org/10.1056/NEJMoa1716948
doi: 10.1056/NEJMoa1716948
Nishio M, Barlesi F, West H, Ball S, Bordoni R, Cobo M, Longeras PD, Goldschmidt J Jr, Novello S, Orlandi F, Sanborn RE, Szalai Z, Ursol G, Mendus D, Wang L, Wen X, McCleland M, Hoang T, Phan S, Socinski MA, Plus A (2021) Atezolizumab plus chemotherapy for first-line treatment of nonsquamous NSCLC: results from the randomized phase 3 IMpower132 trial. J Thorac Oncol 16:653–664. https://doi.org/10.1016/j.jtho.2020.11.025
doi: 10.1016/j.jtho.2020.11.025
pubmed: 33333328
Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora JE, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O’Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS (2019) Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. N Engl J Med 381:2020–2031. https://doi.org/10.1056/NEJMoa1910231
doi: 10.1056/NEJMoa1910231
pubmed: 31562796
Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M (2021) First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol 22:198–211. https://doi.org/10.1016/S1470-2045(20)30641-0
doi: 10.1016/S1470-2045(20)30641-0
pubmed: 33476593
Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR (2020) Atezolizumab for first-line treatment of PD-L1–selected patients with NSCLC. N Engl J Med 383:1328–1339. https://doi.org/10.1056/NEJMoa1917346
doi: 10.1056/NEJMoa1917346
pubmed: 32997907
Spratlin JL, Cohen RB, Eadens M, Gore L, Camidge DR, Diab S, Leong S, O’Bryant C, Chow LQ, Serkova NJ, Meropol NJ, Lewis NL, Chiorean EG, Fox F, Youssoufian H, Rowinsky EK, Eckhardt SG (2010) Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2. J Clin Oncol 28:780–787. https://doi.org/10.1200/JCO.2009.23.7537
doi: 10.1200/JCO.2009.23.7537
pubmed: 20048182
pmcid: 2834394
Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Pérol M (2014) Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 384:665–673. https://doi.org/10.1016/S0140-6736(14)60845-X
doi: 10.1016/S0140-6736(14)60845-X
pubmed: 24933332
Yoh K, Hosomi Y, Kasahara K, Yamada K, Takahashi T, Yamamoto N, Nishio M, Ohe Y, Koue T, Nakamura T, Enatsu S, Lee P, Ferry D, Tamura T, Nakagawa K (2016) A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy. Lung Cancer 99:186–193. https://doi.org/10.1016/j.lungcan.2016.07.019
doi: 10.1016/j.lungcan.2016.07.019
pubmed: 27565938
Kato R, Hayashi H, Chiba Y, Miyawaki E, Shimizu J, Ozaki T, , Fujimoto D, Toyozawa R, Nakamura A, Kozuki T, Tanaka K, Teraoka S, Usui K, Nishino K, Hataji O, Ota K, Ebi N, Saeki S, Akazawa Y, Okuno M, Yamamoto N, Nakagawa K (2020) Propensity score-weighted analysis of chemotherapy after PD-1 inhibitors versus chemotherapy alone in patients with non-small cell lung cancer (WJOG10217L). J Immunother Cancer 8(1):e000350. https://doi.org/10.1136/jitc-2019-000350
Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F (2004) Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184–2191. https://doi.org/10.1200/JCO.2004.11.022
doi: 10.1200/JCO.2004.11.022
pubmed: 15169807
Freites-Martinez A, Santana N, Arias-Santiago S, Viera A (2021) Using the common terminology criteria for adverse events (CTCAE - version 5.0) to evaluate the severity of adverse events of anticancer therapies. Actas Dermo-sifiliogr (Engl) 112:90–92. https://doi.org/10.1016/j.ad.2019.05.009
doi: 10.1016/j.ad.2019.05.009
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–247. https://doi.org/10.1016/j.ejca.2008.10.026
doi: 10.1016/j.ejca.2008.10.026
pubmed: 19097774
Baggstrom MQ, Waqar SN, Sezhiyan AK, Gilstrap E, Gao F, Morgensztern D, Govindan R (2011) Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials. J Thorac Oncol 6:98–102. https://doi.org/10.1097/JTO.0b013e3181fb50d8
doi: 10.1097/JTO.0b013e3181fb50d8
pubmed: 21150469
Kawachi H, Fujimoto D, Morimoto T, Ito M, Teraoka S, Sato Y, Nagata K, Nakagawa A, Otsuka K, Tomii K (2018) Clinical characteristics and prognosis of patients with advanced non-small-cell lung cancer who are ineligible for clinical trials. Clin Lung Cancer 19:e721–e734. https://doi.org/10.1016/j.cllc.2018.05.014
doi: 10.1016/j.cllc.2018.05.014
pubmed: 29934133
Truong J, Lee EK, Trudeau ME, Chan KK (2016) Interpreting febrile neutropenia rates from randomized, controlled trials for consideration of primary prophylaxis in the real world: a systematic review and meta-analysis. Ann Oncol 27:608–618. https://doi.org/10.1093/annonc/mdv619
doi: 10.1093/annonc/mdv619
pubmed: 26712901
Shukuya T, Takahashi T, Kaira R, Ono A, Nakamura Y, Tsuya A, Kenmotsu H, Naito T, Kaira K, Murakami H, Endo M, Takahashi K, Yamamoto N (2011) Efficacy of gefitinib for non-adenocarcinoma non-small-cell lung cancer patients harboring epidermal growth factor receptor mutations: a pooled analysis of published reports. Cancer Sci 102:1032–1037. https://doi.org/10.1111/j.1349-7006.2011.01887.x
doi: 10.1111/j.1349-7006.2011.01887.x
pubmed: 21272159
Tian W, Cao C, Shu L, Wu F (2020) Anti-angiogenic therapy in the treatment of non-small cell lung cancer. Onco Targets Ther 13:12113–12129. https://doi.org/10.2147/OTT.S276150
doi: 10.2147/OTT.S276150
pubmed: 33262610
pmcid: 7699985
Hegde PS, Wallin JJ, Mancao C (2018) Predictive markers of anti-VEGF and emerging role of angiogenesis inhibitors as immunotherapeutics. Semin Cancer Biol 52:117–124. https://doi.org/10.1016/j.semcancer.2017.12.002
doi: 10.1016/j.semcancer.2017.12.002
pubmed: 29229461
Chouaib S, Messai Y, Couve S, Escudier B, Hasmim M, Noman MZ (2012) Hypoxia promotes tumor growth in linking angiogenesis to immune escape. Front Immunol 3:21. https://doi.org/10.3389/fimmu.2012.00021
doi: 10.3389/fimmu.2012.00021
pubmed: 22566905
pmcid: 3341970
Khan KA, Kerbel RS (2018) Improving immunotherapy outcomes with anti-angiogenic treatments and vice versa. Nat Rev Clin Oncol 15:310–324. https://doi.org/10.1038/nrclinonc.2018.9
doi: 10.1038/nrclinonc.2018.9
pubmed: 29434333
Shiraishi Y, Kishimoto J, Tanaka K, Sugawara S, Daga H, Hirano K, Azuma K, Hataji O, Hayashi H, Tachihara M, Mitsudomi T, Seto T, Nakagawa K, Yamamoto N, Okamoto I (2020) Treatment rationale and design for APPLE (WJOG11218L): A multicenter, open-label, randomized phase 3 study of atezolizumab and platinum/pemetrexed with or without bevacizumab for patients with advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer 21:472–476. https://doi.org/10.1016/j.cllc.2020.03.010
doi: 10.1016/j.cllc.2020.03.010
pubmed: 32381420
Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L (2021) Phase 1 expansion cohort of ramucirumab plus pembrolizumab in advanced treatment-naive NSCLC. J Thorac Oncol 16:289–298. https://doi.org/10.1016/j.jtho.2020.10.004
doi: 10.1016/j.jtho.2020.10.004
pubmed: 33068794