Ipilimumab versus ipilimumab plus anti-PD-1 for metastatic melanoma – Authors' reply

• Published in: The lancet oncology Vol. 22; no. 8; pp. e343 - e344
• Main Authors: da Silva, Ines Pires, Ahmed, Tasnia, Reijers, Irene L M, Warner, Allison Betof, Patrinely, James Randall, Serra-Bellver, Patricio, Allayous, Clara, Mangana, Joanna, Zimmer, Lisa, Trojaniello, Claudia, Klein, Oliver, Gerard, Camille L, Michielin, Olivier, Haydon, Andrew, Ascierto, Paolo A, Carlino, Matteo S, Lebbe, Celeste, Lorigan, Paul, Johnson, Douglas B, Sandhu, Shahneen, Lo, Serigne N, Menzies, Alexander M, Long, Georgina V
• Format: Journal Article
• Language: English
• Published: London Elsevier Ltd 01.08.2021; Elsevier Limited
• Subjects: Dehydrogenases; L-Lactate dehydrogenase; Lactic acid; Medical prognosis; Melanoma; Metastases; Patients; PD-1 protein; Statistical analysis; Survival
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(21)00419-8

[...]exploratory analyses were removed in the editorial process. To expand on this point, differences in baseline characteristics between the two treatment groups were observed, including ECOG performance status, age, and mutational status.1 Our multivariable analysis included many potential confounding variables (ECOG performance status, sex, age, sites of metastases, and lactate dehydrogenase level, among others) and found treatment was an independent predictor for both objective response and overall survival (favouring the ipilumumab plus anti-PD-1 combination). ECOG performance status was only significantly associated with overall survival (not with objective response), suggesting that ECOG performance status is predominantly prognostic, consistent with the pooled analysis that Li cited by Hauschild and colleagues,2 and with other studies.3,4 In the subgroup analysis (including an interaction term),1 we showed there was no statistically significant difference in objective response between the treatment groups for patients with an ECOG performance status of 1 or higher (ten [17%] of 58 patients in the combination group vs 12 [13%] of 95 in the monotherapy group; odds ratio 0·69 [95% CI 0·28–1·72]). [...]there was a higher objective response rate with the combination compared with ipilimumab monotherapy in most other prespecified subgroups (half were statistically significant), except for patients with a BRAF mutation.