[Advanced Medical Care].

Area of Science:

• Oncology
• Clinical Trials
• Pharmacoeconomics

Background:

• Pemetrexed is not approved for resected non-small cell lung cancer (NSCLC) in Japan.
• Advanced medical care systems facilitate insurance reimbursement for off-label treatments and clinical trials.
• Academia-led clinical trials for unapproved drugs face hurdles in Japan.

Purpose of the Study:

• To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as adjuvant chemotherapy.
• To assess recurrence-free survival as the primary endpoint in stage II-IIIA nonsquamous NSCLC patients.

Main Methods:

• A randomized phase III study (JIPANG) was conducted.
• The study involved a 5-year registration period and 5-year follow-up.
• Participants had stage II-IIIA nonsquamous NSCLC.

Main Results:

• Pemetrexed plus cisplatin did not demonstrate superiority over vinorelbine plus cisplatin.
• The primary endpoint, recurrence-free survival, was not improved by the pemetrexed-based regimen.

Conclusions:

• The JIPANG study failed to confirm the superiority of pemetrexed plus cisplatin for adjuvant treatment of resected NSCLC.
• Challenges in drug provision, funding, and establishing trial systems impede academia-led trials for unapproved drugs in Japan.