1. First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial
- Author
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Jean Philippe Spano, Jacques Cadranel, Alexandra Langlais, H. Janicot, Xavier Quantin, Clarisse Audigier-Valette, Armelle Lavolé, Lena Herve, Franck Morin, Alain Makinson, Philippe Fraisse, Isabelle Monnet, Laurent Greillier, Lize Kiakouama-Maleka, and Julien Mazieres
- Subjects
Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,Lung Neoplasms ,Anemia ,medicine.medical_treatment ,HIV Infections ,Pemetrexed ,Neutropenia ,Carboplatin ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Carcinoma ,Humans ,030212 general & internal medicine ,Lung cancer ,business.industry ,Immunotherapy ,medicine.disease ,Clinical trial ,Treatment Outcome ,chemistry ,030220 oncology & carcinogenesis ,business ,medicine.drug - Abstract
PurposeHIV infection is an exclusion criterion in lung cancer trials. This multicenter phase II trial aimed to assess feasibility, efficacy and safety of first-line carboplatin plus pemetrexed (CaP) followed by pemetrexed (P) maintenance in people living with HIV (PLHIV) with advanced non-squamous non-small cell lung cancer (NS-NSCLC).MethodsFour cycles of CaP were followed by P-maintenance therapy in patients with Eastern Cooperative Oncology Group performance status (PS) ≤2. The primary objective was a disease control rate (DCR) ≥30% after 12 weeks.ResultsOf the 61 PLHIV enrolled 49 (80%) had a PS 0–1, 19 (31%) brain metastases. Median CD4 lymphocyte count was 418 cells·µL−1(range: 18–1230), median CD4 lymphocyte nadir 169.5 cells·µL−1(1–822); 48 patients (80%) were virologically controlled. Four-cycle inductions were achieved by 38 patients (62%), and 31 (51%) started P maintenance [median of 4.1 cycles (range: 1–19)]. The 12-week DCR was 50.8% (95%CI: 38.3;63.4) and partial response rate 21.3%. Median PFS and OS were respectively 3.5 (95%CI: 2.7;4.4) and 7.6 months (5.7;12.8). Patients with PS 0–1 had the longest median PFS (4.3 months, 95%CI: 3.1;5.2) and OS (11.9 months, 95%CI: 6.4;14.3). During induction, CaP doublet was well tolerated apart from grade 3–4 hematologic toxicities (neutropenia, 53.8%; thrombocytopenia, 35.0%; anemia, 30.0%). Two fatal treatment-related sepsis were reported. No opportunistic infections were experienced.ConclusionIn PLHIV with advanced NS-NSCLC, first-line 4-cycle CaP induction followed by P maintenance was effective and reasonably well-tolerated. Further studies should evaluate combination strategies of CaP with immunotherapy in PLHIV.
- Published
- 2019