Comparative Cost-Effectiveness of Gemcitabine and Cisplatin in Combination with S-1, Durvalumab, or Pembrolizumab as First-Line Triple Treatment for Advanced Biliary Tract Cancer

Article

Author: Maeda, Hiroyuki ; Kashiwa, Munenobu

PURPOSEThe clinical effectiveness of triple chemotherapy consisting of gemcitabine, cisplatin plus either S-1 (GCS), durvalumab (DGC), or pembrolizumab (PGC) as first-line treatment for advanced biliary tract cancer (BTC) has been reported. However, their comparative cost-effectiveness is unclear. We conducted a model-based cost-effectiveness analysis from the perspective of Japanese healthcare payer.METHODSA 10-year partitioned survival model was constructed by comparing the time-dependent hazards of the KHBO1401-MITSUBA, TOPAZ-1, and KEYNOTE-966 trials. The cost and utility came from previously published reports. Quality-adjusted life years (QALY) were used to measure the effects on health. Costs for direct medical care were taken into account. There was a one-way analysis and a probability sensitivity analysis. A willingness-to-pay threshold of 7.5 million yen (57,034 USD) per QALY was defined.RESULTSThe incremental costs per QALY for GCS, DGC, and PGC in the base case study were 3,779,374 JPY (28,740 USD), 86,058,056 JPY (65,4434 USD), and 28,982,059 JPY (220,396 USD), respectively. No parameter had an influence beyond the threshold in a one-way sensitivity analysis. A probabilistic sensitivity analysis revealed that the probability of GCS, DGC, and PGC being cost-effective at the threshold was 85.6%, 0%, and 0%, respectively.CONCLUSIONGiven the current circumstances, it is probable that triple therapy utilizing GCS will emerge as a plausible and efficient primary chemotherapy strategy for patients with advanced BTC in the Japanese healthcare system, as opposed to DGC and PGC.

01 Nov 2024·Cancer Reports

A Case of Advanced Biliary Tract Cancer With EGFR Amplification That Responded to Necitumumab

Article

Author: Nishimura, Masaki ; Hirose, Haruka ; Sugimori, Kazuya ; Inayama, Yoshiaki ; Numata, Kazushi ; Tsuyuki, Sho ; Sugimori, Makoto ; Hirotani, Akane ; Miwa, Haruo ; Nozaki, Akito ; Kunisaki, Chikara ; Kaneko, Takashi ; Maeda, Shin

ABSTRACTBackgroundRecent advances in cancer genome analysis and the practice of precision medicine have made it possible to identify fractions with rare genetic alterations. Among biliary tract cancers, EGFR‐amplified cancers are known to be rare fractions across organs and have a poor prognosis. The use of anti‐EGFR antibody for EGFR‐amplified cancers has been promising; however, the evidence is not yet clear.CaseIn this report, we describe the case of a 48‐year‐old man diagnosed with advanced gallbladder cancer. The patient was administered gemcitabine plus cisplatin, followed by S‐1 monotherapy; however, disease progression was observed after two cycles of each regimen. Comprehensive genomic profiling test revealed EGFR‐amplification, and the patient was treated with combination therapy with the anti‐EGFR antibody necitumumab, gemcitabine, and cisplatin. After two cycles of treatment, tumor size reduced, and the treatment response was evaluated as partial response. On Day 90, after five cycles of treatment, tumor progression was confirmed. In addition, after disease progression, liquid biopsy revealed acquired pathogenic gene alterations suggesting anti‐EGFR antibody resistance.ConclusionThis report supports the clinical benefit of anti‐EGFR antibodies for EGFR‐amplified biliary tract cancers and the importance of genomic analysis in personalized therapy and drug resistance research.

01 Sep 2024·Journal of Clinical Oncology

Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY

Article

Author: Park, ChoHyun ; Kim, Hyunki ; Sul, Ji Young ; Oh, Sang Cheul ; Noh, Sung Hoon ; Kim, In-Ho ; Cheong, Jae-Ho ; Ryoo, Baek-Yeol ; Kim, Hyung-Don ; Yook, Jeong Hwan ; Kim, Jong Gwang ; Lee, Jong Seok ; Lee, Nam Su ; Park, Young-Kyu ; Kim, Young-Woo ; Lee, Sang Ho ; Zang, Dae Young ; Rha, Sun Young ; Beom, Seung-Hoon ; Jang, You Jin ; Hwang, Jun-Eul ; Kang, Yoon-Koo ; Kim, Hark Kyun ; Kim, Beom Su ; Park, Young Soo ; Kim, Jin Young ; Ryu, Min-Hee ; Jeong, Oh ; Chung, Ik Joo ; Yoo, Chang Hak ; Kang, Seok Yun ; Heo, Mi Hwa ; Kook, Myeong-Cherl ; Yoo, Moon-Won ; Ryu, Seung Wan

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The phase III PRODIGY study demonstrated that neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 chemotherapy (CSC) improved progression-free survival (PFS) compared with surgery followed by adjuvant S-1 (SC) for patients with resectable locally advanced gastric cancer (LAGC) with clinical T2-3N+ or T4Nany disease. The primary end point was PFS. Overall survival (OS) was the secondary end point. We herein report the long-term follow-up outcomes, including OS, from this trial. A total of 238 and 246 patients were randomly assigned to the CSC and SC arms, respectively, and were treated (full analysis set). As of the data cutoff (September 2022), the median follow-up duration of the surviving patients was 99.5 months. Compared with SC, CSC significantly increased the OS (adjusted hazard ratio [HR], 0.72; stratified log-rank P = .027) with an 8-year OS rate of 63.0% and 55.1% for the CSC and SC arms, respectively. CSC also significantly improved the PFS (HR, 0.70; stratified log-rank P = .016). In conclusion, neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, prolonged the OS of Asian patients with LAGC relative to patients treated with surgery and adjuvant S-1. It should be considered one of the standard treatment options for patients with LAGC in Asia.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Preclinical	US	Duquesne University of The Holy Spirit	05 Aug 2011

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