PMID- 30285770 OWN - NLM STAT- MEDLINE DCOM- 20181221 LR - 20181221 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 18 IP - 1 DP - 2018 Oct 3 TI - Efficacy of anti-PD-1/PD-L1 antibodies after discontinuation due to adverse events in non-small cell lung cancer patients (HANSHIN 0316). PG - 946 LID - 10.1186/s12885-018-4819-2 [doi] LID - 946 AB - BACKGROUND: Immune checkpoint inhibitors (ICIs) have emerged as promising therapeutic agents in non-small cell lung cancer (NSCLC). However, the duration for which ICIs should be continued remains a clinical problem. METHODS: We examined the efficacy of anti-PD-1/PD-L1 inhibitors after the discontinuation of antibodies due to adverse events (AEs) in patients with NSCLC. This was a multicenter retrospective study that analyzed NSCLC patients who were treated with PD-1/PD-L1 inhibitors by August 2016. RESULTS: The patients with NSCLC were 18 males and 1 female at a median 67 years of age (range: 49-80 years). Eighteen of 19 patients were treated with nivolumab, one was with atezolizumab. Approximately half of AEs were interstitial pneumonia. Fourteen patients (73.7%) were treated with steroid therapy. The median number of treatment cycles was 7 (range, 1-70), and the median duration of treatment was 2.8 months (range, 1 day-32.9 months). The overall response rate with confirmation during treatment was 21.1%. The median progression-free survival (PFS) was 10.2 months (95% confidence interval [CI] = 3.2-17.1 months) and 5.6 months (95% CI = 0-12.2 months) from the initiation and the discontinuation of PD-1/PD-L1 treatment, respectively. The median PFS after discontinuation according to the confirmed response during administration was not reached for partial response (PR) and 4.9 months (95% CI, 3.7-6.0) for stable disease (SD) patients (P = 0.02). CONCLUSION: The PFS of the PR patients was completely different from that of the SD patients. The cases with PR prior to the onset of AE tended to show a durable response after the discontinuation of PD-1/PD-L1 inhibitors. FAU - Tachihara, Motoko AU - Tachihara M AD - Department of Respiratory Medicine, Kobe University Graduate School of Medicine, 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe-city, Hyogo, 650-0017, Japan. mt0318@med.kobe-u.ac.jp. FAU - Negoro, Shunichi AU - Negoro S AD - Department of Medical Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan. FAU - Inoue, Takako AU - Inoue T AD - Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-Ku, Osaka-shi, Osaka, 541-8567, Japan. FAU - Tamiya, Motohiro AU - Tamiya M AD - Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-Ku, Osaka-shi, Osaka, 541-8567, Japan. FAU - Akazawa, Yuki AU - Akazawa Y AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. FAU - Uenami, Takeshi AU - Uenami T AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. FAU - Urata, Yoshiko AU - Urata Y AD - Department of Thoracic Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan. FAU - Hattori, Yoshihiro AU - Hattori Y AD - Department of Thoracic Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan. FAU - Hata, Akito AU - Hata A AD - Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan. FAU - Katakami, Nobuyuki AU - Katakami N AD - Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan. FAU - Yokota, Soichiro AU - Yokota S AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. LA - eng PT - Journal Article DEP - 20181003 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Antineoplastic Agents, Immunological) RN - 0 (B7-H1 Antigen) RN - 0 (CD274 protein, human) RN - 0 (Programmed Cell Death 1 Receptor) SB - IM MH - Aged MH - Antineoplastic Agents, Immunological/administration & dosage/adverse effects/*therapeutic use MH - B7-H1 Antigen/*antagonists & inhibitors MH - Carcinoma, Non-Small-Cell Lung/diagnosis/*drug therapy/mortality MH - Disease Progression MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Lung Neoplasms/diagnosis/*drug therapy/mortality MH - Male MH - Middle Aged MH - Molecular Targeted Therapy MH - Programmed Cell Death 1 Receptor/*antagonists & inhibitors MH - Treatment Outcome PMC - PMC6171229 OTO - NOTNLM OT - Adverse event OT - Anti-PD-1/L1 inhibitor OT - Discontinuation OT - Non-small cell lung cancer COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This research conformed to the provisions of the Declaration of Helsinki. This retrospective study was approved by the ethics committee of Kobe University (approval No.160122) and each institutions. Consent to participate: this is a retrospective study and consent to participate was waived by the Ethics Committee of Kobe University and each institution. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/10/05 06:00 MHDA- 2018/12/24 06:00 PMCR- 2018/10/03 CRDT- 2018/10/05 06:00 PHST- 2018/04/05 00:00 [received] PHST- 2018/09/13 00:00 [accepted] PHST- 2018/10/05 06:00 [entrez] PHST- 2018/10/05 06:00 [pubmed] PHST- 2018/12/24 06:00 [medline] PHST- 2018/10/03 00:00 [pmc-release] AID - 10.1186/s12885-018-4819-2 [pii] AID - 4819 [pii] AID - 10.1186/s12885-018-4819-2 [doi] PST - epublish SO - BMC Cancer. 2018 Oct 3;18(1):946. doi: 10.1186/s12885-018-4819-2.