Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• The lancet oncology, 2021-08, Vol.22 (8), p.e343-e344

Ort / Verlag

London: Elsevier Ltd

Erscheinungsjahr

2021

Quelle

Elsevier ScienceDirect Journals Complete

Beschreibungen/Notizen

• [...]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.