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Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

5626 - JIPANG study: Randomized Phase III Study of pemetrexed/cisplatin (PEM/Cis) versus vinorelbine /cisplatin (VNR/Cis) for completely resected p-stage II-IIIA non-squamous non-small cell lung cancer (Ns-NSCLC): Outcomes based on EGFR mutation status

Date

29 Sep 2019

Session

Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

Presenters

Masahiro Tsuboi

Citation

Annals of Oncology (2019) 30 (suppl_5): v585-v590. 10.1093/annonc/mdz258

Authors

M. Tsuboi1, H. Kenmotsu2, T. Yamanaka3, K. Yoshiya4, T. Takahashi5, T. Ueno6, K. Goto7, H. Daga8, N. Ikeda9, K. Sugio10, T. Seto11, S. Toyooka12, H. Date13, T. Mitsudomi14, I. Okamoto15, K. Yokoi16, H. Saka17, H. Okamoto18, Y. Takiguchi19, N. Yamamoto20

Author affiliations

  • 1 Thoracic Surgery And Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Nagaizumi/JP
  • 3 Department Of Biostatistics, Yokohama City University School of Medicine, 236-004 - Yokohama/JP
  • 4 Chest Surgery, Niigata Cancer Center Hospital, Niigata/JP
  • 5 Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 6 Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama/JP
  • 7 Thoracic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 8 Department Of Medical Oncology, Osaka City General Hospital, 534-0021 - Osaka/JP
  • 9 Department Of Surgery, Tokyo Medical University, Tokyo/JP
  • 10 Department Of Thoracic And Breast Surgery, Oita University Faculty of Medicine, 879-5593 - Yufu/JP
  • 11 Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 12 General Thoracic Surgery, Breast And Endocrinological Surgery, Okayama University, Okayama/JP
  • 13 Thoracic Surgery, Graduate School of Medicine, Kyoto University, Kyoto/JP
  • 14 Surgery, KIndai University Faculty of Medicine, Osaka-Sayama/JP
  • 15 Research Institute For Disease Of The Chest, Kyushu University Faculty of Medicine, Fukuoka/JP
  • 16 Thoracic Surgery, Nagoya University, Nagoya/JP
  • 17 Respiratory Medicine, National Hospital Organization Nagoya Medical Center, 4600001 - Nagoya/JP
  • 18 Department Of Respiratory Medicine And Medical Oncology, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 19 Department Of Medical Oncology, Chiba University, 260-8670 - Chiba/JP
  • 20 Internal Medicine And Medical Oncology, Wakayama Medical University, 641-8509 - Wakayama/JP
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Abstract 5626

Background

The VNR/Cis chemotherapy doublet has been evaluated in prior positive adjuvant trials in patients with completely resected Ns-NSCLC, whereas no phase III study has so far evaluated PEM/Cis in this population. And there are few data regarding outcomes based on EGFR mutation (EGFRm) status in adjuvant chemotherapies.

Methods

Patients with completely resected Ns-NSCLC were randomized in a 1:1 ratio to receive either PEM (500 mg/m2, day 1)/Cis (75 mg/m2, day 1) or VNR (25 mg/m2, days 1 and 8)/Cis (80 mg/m2, day 1), and stratified according to sex, age, pathologic stage, EGFRm status and institution. The primary endpoint was recurrence-free survival (RFS), and, the planned sample size was 800 patients in total (Trial Identifier, UMIN000006737).

Results

Between March 2012 and August 2016, 804 patients were randomized. Of 784 for the efficacy analysis (389 in PEM/Cis and 395 in VNR/Cis), median age was 65/65 years; stage IIIA 52.2%/52.4%; adenocarcinoma, 95.9%/95.9%; and EGFR mutation, 24.1%/24.9%. With a median follow-up of 45.2 months (mo), median RFS was 38.9mo in PEM/Cis and 37.3mo in VNR/Cis with a hazard ratio (HR) of 0.98 (95% CI, 0.81--1.20; log-rank test, P = 0.948), whereas HRs in patients with or without EGFRm were 1.38 (95% CI, 0.95--1.99) and 0.87 (95% CI, 0.69--1.09), respectively (Interaction, P = 0.046). As for patients without EGFRm, median RFS was 65.2mo in PEM/Cis and 39.9mo in VNR/Cis. The overall survival rate at 3 years was 83.5% versus 87.2% with a HR of 0.98 (95% CI, 0.71 --1.35). Rates of treatment completion were 87.9% (PEM/Cis) and 72.7% (VNR/Cis), respectively (P < 0.001). Incidences of grade 3 or 4 febrile neutropenia (11.6/0.3%, P < 0.001), neutropenia (81.1/22.8%, P < 0.001), and anemia (9.3/2.8%, P < 0.001); any grade alopecia (30.1/12.8%, P < 0.001).

Conclusions

Although this phase III study did not meet the primary endpoint, PEM/CDDP had a similar efficacy to VNR/CDDP with a better tolerability as postoperative adjuvant chemotherapy for Ns-NSCLC patients. A significant interaction for RFS was found between treatment and EGFR mutation status. In patients without EGFR mutation, PEM/Cis seems to be a preferable regimen as the adjuvant chemotherapy.

Clinical trial identification

UMIN000006737.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Health and Labor Sciences Research Grants, The Japan Agency of Medical Research and Development (AMED).

Disclosure

M. Tsuboi: Honoraria (self): AstraZeneca KK; Honoraria (self): Johnson & Johnson Japan; Honoraria (self): MSD; Honoraria (self): Chugai Pharmaceutical Co., Ltd.; Honoraria (self): Taiho Pharma; Honoraria (self): Eli Lilly Japan; Honoraria (self): Boehringer Ingelheim Japan; Honoraria (self): Ono Pharmaceutical Co., Ltd; Honoraria (self): Bristol-Myers Squibb KK; Honoraria (self): Daiichi-Sankyo; Honoraria (self): Covidien Japan; Honoraria (self): Teijin Pharma; Research grant / Funding (institution): Boehringer Ingelheim Japan. All other authors have declared no conflicts of interest.

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