PT - JOURNAL ARTICLE AU - Armelle Lavole AU - Laurent Greillier AU - Julien Mazières AU - Isabelle Monnet AU - Lize Kiakouama-Maleka AU - Xavier Quantin AU - Jean Philippe Spano AU - Lena Herve AU - Philippe Fraisse AU - Henri Janicot AU - Clarisse Audigier-Valette AU - Alexandra Langlais AU - Franck Morin AU - Alain Makinson AU - Jacques Cadranel ED - , TI - First-Line Carboplatin Plus Pemetrexed with Pemetrexed Maintenance in HIV+ Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer: The Phase II IFCT-1001 CHIVA Trial AID - 10.1183/13993003.02066-2019 DP - 2020 Jan 01 TA - European Respiratory Journal PG - 1902066 4099 - http://erj.ersjournals.com/content/early/2020/07/23/13993003.02066-2019.short 4100 - http://erj.ersjournals.com/content/early/2020/07/23/13993003.02066-2019.full AB - Purpose HIV 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).Methods Four 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.Results Of 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.Conclusion In 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. LAVOLE has nothing to disclose.Conflict of interest: Dr. Greillier reports personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Roche, personal fees from Bristol-Myers Squibb, personal fees from MSD, personal fees from Takeda, personal fees from Abbvie, personal fees from Novartis, outside the submitted work; and Travel, accomodations, expenses: MSD, Pfizer.Conflict of interest: Dr. MAZIERES has nothing to disclose.Conflict of interest: Dr. MONNET has nothing to disclose.Conflict of interest: Dr. KIAKOUAMA-MALEKA has nothing to disclose.Conflict of interest: Dr. QUANTIN has nothing to disclose.Conflict of interest: Dr. Spano reports personal fees from MSD, personal fees from Roche, personal fees from Lilly, personal fees from Mylan, personal fees from Pfizer, personal fees from Pierre Fabre Oncology, personal fees from leopharma, personal fees from Novartis, personal fees from Biogaran, personal fees from Astra zeneca, personal fees from Gilead, grants from BMS, grants from MSD Avenir, outside the submitted work;.Conflict of interest: Dr. LENA has nothing to disclose.Conflict of interest: Dr. FRAISSE has nothing to disclose.Conflict of interest: Dr. JANICOT has nothing to disclose.Conflict of interest: Dr. AUDIGIER-VALETTE has nothing to disclose.Conflict of interest: Dr. LANGLAIS has nothing to disclose.Conflict of interest: Dr. MORIN has nothing to disclose.Conflict of interest: Dr. MAKINSON has nothing to disclose.Conflict of interest: Dr. Cadranel reports grants from AstraZeneca, grants from Novartis, grants from Pfizer, outside the submitted work.