Pharmacokinetic and pharmacogenomic analysis of low-dose afatinib treatment in elderly patients with EGFR mutation-positive non–small cell lung cancer

Author(s):  
Hidenori Mizugaki ◽  
Satoshi Oizumi ◽  
Yuka Fujita ◽  
Toshiyuki Harada ◽  
Yoshiro Nakahara ◽  
...  
JAMA Oncology ◽  
2020 ◽  
Vol 6 (7) ◽  
pp. e201250 ◽  
Author(s):  
Shingo Miyamoto ◽  
Koichi Azuma ◽  
Hidenobu Ishii ◽  
Akihiro Bessho ◽  
Shinobu Hosokawa ◽  
...  

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e20519-e20519
Author(s):  
Chunlei Shi ◽  
Aiqin Gu ◽  
Liwen Xiong ◽  
Yuping LI ◽  
Xiaohong Cai ◽  
...  

2014 ◽  
Vol 74 (4) ◽  
pp. 721-727 ◽  
Author(s):  
Kosuke Takahashi ◽  
Hiroshi Saito ◽  
Yoshinori Hasegawa ◽  
Masahiko Ando ◽  
Masashi Yamamoto ◽  
...  

Author(s):  
Ryo Shimoyama ◽  
Shota Omori ◽  
Shogo Nomura ◽  
Hirotsugu Kenmotsu ◽  
Toshiaki Takahashi ◽  
...  

Abstract Daily low-dose carboplatin plus concurrent thoracic radiotherapy is the standard treatment for elderly patients with unresectable clinical stage (c-Stage) III non-small cell lung cancer (NSCLC) in Japan. However, a phase I study by Omori et al. suggests that weekly carboplatin and nab-paclitaxel plus concurrent thoracic radiotherapy have comparable efficacy outcomes with more manageable adverse events. In December 2020, we initiated a randomized controlled trial in Japan to confirm whether the weekly carboplatin plus nab-paclitaxel regimen is noninferior to the daily low-dose carboplatin regimen for concurrent chemoradiotherapy in elderly patients with unresectable c-Stage III NSCLC. We plan to enroll 166 patients from 50 institutions in 3.5 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate, proportion of patients starting maintenance durvalumab therapy, adverse events, site of progression, Functional Assessment of Cancer Therapy–Trial Outcome Index deterioration and Instrumental Activities of Daily Living deterioration.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20658-e20658
Author(s):  
Hideki Kusagaya ◽  
Naoki Inui ◽  
Masato Karayama ◽  
Yuichi Ozawa ◽  
Yutaro Nakamura ◽  
...  

e20658 Background: Chemotherapy regimens for the elderly with non-small-cell lung cancer (NSCLC) are still controversial, especially for patients over 80 years. We previously reported that biweekly combination therapy with gemcitabine and low-dose carboplatin was well tolerated and active in elderly patients aged ≥76 years with NSCLC (Lung Cancer 77, 2012). Here we present a subanalysis of more elder patients aged ≥80 years. Methods: We conducted a phase II trial comparing biweekly combination therapy with gemcitabine (1000mg/m2) plus carboplatin (AUC 3) and monotherapy with weekly gemcitabine (1000mg/m2) in chemotherapy-naïve NSCLC patients aged ≥76 years. We performed a retrospective subgroup analysis comparing patients aged < 80 and those ≥ 80 years. We focused on patients treated with combination therapy. The primary endpoint was overall response rate and secondary endpoints were safety and progression free survival (PFS). Results: Sixteen patients were aged < 80 years (median 77.5, range, 76-79 years) and 15 patients were aged ≥80 years (median 83, range 81-88 years). Overall response rates were 25% (95% CI: 7.3-52.4%) for patients aged <80 years and 20% (95% CI: 4.3-48.1%) for patients aged ≥80 years. The median PFS in patients aged <80 years was 3.5 months (95% CI: 3.2-5.6), compared with 3.6 months (95% CI: 2.8-5.0) in patients aged ≥80 years. Additionally, the prevalence of grade 3 or 4 hematologic and non-hematologic toxicity, the completion of four cycles chemotherapy, and the need for withdrawing treatment were not significantly different between the two groups. Conclusions: In elderly patients with NSCLC, even aged ≥80 years, combination therapy with biweekly gemcitabine and low-dose carboplatin may be an efficacious treatment with a favorable toxicity profile. Clinical trial information: NCT00881296.


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