Short-term efficacy of advanced NSCLC patients receiving anlotinib hydrochloride as the first and second-line treatment

Author(s):  
Changning Changning ◽  
Yong Zhang ◽  
Jian Zhang
2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8042-8042 ◽  
Author(s):  
Jinji Yang ◽  
Ying Cheng ◽  
Mingfang Zhao ◽  
Qing Zhou ◽  
Hong hong Yan ◽  
...  

8042 Background: Pemetrexed or gefitinib is one of the standard second-line treatments for advanced non-squamousNSCLC in East Asia. The CTONG 0806 a multi-center, randomized, controlled, open-label phase II trial was designed to explore the efficacy of pemetrexed versus gefitinib as the second-line treatment in advanced NSCLC patients without EGFR mutation. Methods: The patients with locally advanced or metastatic, non-squamous NSCLC previously treated with platinum-based chemotherapy and no EGFR mutation in exons 18-21 were enrolled. Patients were 1:1 randomized to receive either gefitinib 250 mg per oral every day (G arm) or pemetrexed 500 mg/m2 iv day 1 with vitamin B12 and folic acid supplement every 21 days (P arm) until disease progression, unacceptable toxicity, or discontinuation of treatment due to other reason. The primary endpoint was progression-free survival (PFS). The secondary endpoints were 4-month and 6-month progression-free survival rate, overall survival (OS), objective response rate (ORR), quality of life using the FACT-L questionnaire and safety, EGFR and K-ras mutation status were evaluated and correlated with outcomes. Results: From Feb. 2009 to Aug. 2012, 157 evaluable patients were randomized (81 cases in G arm and 76 in P arm). Baseline age, gender, and ECOG performance status were balanced between arms. The primary endpoint of PFS was met with 1.6 months for G arm versus 4.8 months for P arm, the HR is 0.51 (95% CI 0.36~0.73, P<0.001). Overall response rates were 14.7 % and 13.3 % (P=0.814) and DCR were 32.0% and 61.3% (P<0.001) for G arm and P arm, respectively. OS data were not yet mature. More skin rash and diarrhoea were seen in G arm, but more fatigue and ALT increased in P arm. CTCAE grade 3 or 4 of AEs was 12.3% in G arm and 32.9% in P arm (p=0.002). The further analyses of efficacy evaluated by IRR and biomarkers analysis will be presented on the ground. Conclusions: CTONG0806 is the first trial to show significant improvements in PFS and DCR with pemetrexed compared with gefitinib in second-line setting for advanced NSCLC with EGFR wild type. Patients with EGFR wild type did not benefit from EGFR TKI gefitinb in second-line setting. Clinical trial information: NCT00891579.


2021 ◽  
Author(s):  
Mutlu Hizal ◽  
Burak Bilgin ◽  
Nail Paksoy ◽  
Özgür Açıkgöz ◽  
Ahmet Sezer ◽  
...  

Abstract Introduction: Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation.Materials and Methods: This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety.Results: Of 163 patients 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13 months disease follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion: Osimertinib is a highly effective option in second or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.


2007 ◽  
Vol 2 (8) ◽  
pp. S666-S667 ◽  
Author(s):  
Alessandra Bearz ◽  
Isabella Garassino ◽  
Raffaele Cavina ◽  
Adolfo Favaretto ◽  
Massimo Boccalon ◽  
...  

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18058-e18058
Author(s):  
Daisuke Arai ◽  
Kenzo Soejima ◽  
Katsuhiko Naoki ◽  
Shinnosuke Ikemura ◽  
Hideki Terai ◽  
...  

e18058 Background: Both CPT-11 and S-1, which contains a prodrug of 5-FU, have moderate activity against NSCLC as a single agent and the combination of these agents have been reported to possess marked synergistic effects and tolerability in several gastrointestinal cancers. So the combination of CPT-11 and S-1 will be a promising alternative for the second line treatment of NSCLC patients. We have previously reported the phase I study of this combination and determined the recommended doses of these agents. This study was conducted as a phase II trial to evaluate the efficacy and safety of CPT-11 and S-1 for NSCLC patients who had previously treated. Methods: :This trial was open-label, multicenter study. NSCLC patients who had received one prior chemotherapy with performance status 0-1 were enrolled. Primary endopoint was response rate and secondary endpoints were progression free survival, overall survival, 1-year survival rate and adverse events. CPT-11 (60mg/m2 on days1, 8) and oral S-1 (80mg/m2/day on days1-14) was administered on every 21 days, maximally 6 cycles. Results: By October 2011, 31 patients were enrolled. Nineteen were adenocarcinoma and 12 were non-adenocarcinoma. The median age was 60 y/o (range 35-74) and the median number of treatment cycles was 4 (range 1-6). The objective response rates were PR 7.7%, SD 61.5% and PD 30.8%. Median PFS, median OS and 1-year survival rate were 2.8 month, 12.6 month and 55%, respectively. Grade 3-4 hematologic toxicities comprised neutropenia (15%), anemia (11%) and thrombocytopenia (3%). Other grade 3-4 non-hematologic toxicities comprised pneumonitis (7%), diarrhea (3%), anorexia (3%), liver dysfunction (3%) and mucosal disability (3%). No treatment related death was observed. Conclusions: Combination of CPT-11 and oral S-1 was moderately effective with acceptable toxicities as a second line treatment for advanced NSCLC patients.


2015 ◽  
Vol 5 (1) ◽  
Author(s):  
Monica Ganzinelli ◽  
Eliana Rulli ◽  
Elisa Caiola ◽  
Marina Chiara Garassino ◽  
Massimo Broggini ◽  
...  

2021 ◽  
Author(s):  
Xiaoling Shang ◽  
Jianxiang Shi ◽  
Xiaohui Wang ◽  
Chenglong Zhao ◽  
Haining Yu ◽  
...  

Chemotherapy ◽  
2017 ◽  
Vol 62 (4) ◽  
pp. 205-213 ◽  
Author(s):  
Mie Kotake ◽  
Yosuke Miura ◽  
Hisao Imai ◽  
Keita Mori ◽  
Reiko Sakurai ◽  
...  

Background: In patients with non-small-cell lung cancer (NSCLC), the effects of second-line chemotherapy on overall survival (OS) might be confounded by subsequent therapies. Therefore, using individual-level data, we aimed to determine the relationships between progression-free survival (PFS) and post-progression survival (PPS) with OS in patients with advanced NSCLC treated with docetaxel monotherapy as second-line chemotherapy. Methods: Between April 2002 and December 2014, data from 86 patients with advanced NSCLC who underwent second-line docetaxel monotherapy following first-line treatment with platinum combination chemotherapy were analyzed. The relationships of PFS and PPS with OS were analyzed at the individual level. Results: Spearman rank correlation and linear regression analyses showed that PPS was strongly associated with OS (r = 0.86, p < 0.05, R2 = 0.93), whereas PFS was moderately correlated with OS (r = 0.50, p < 0.05, R2 = 0.21). Performance status at the end of second-line treatment and the number of regimens after progression beyond second-line chemotherapy were significantly associated with PPS (p < 0.05). Conclusions: In patients with advanced NSCLC with unknown oncogenic driver mutations undergoing docetaxel monotherapy as second-line chemotherapy, when compared with PFS, PPS had a stronger association with OS. This finding suggests that subsequent treatment after disease progression following second-line docetaxel monotherapy has a significant influence on OS.


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