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Article: Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-lung cancer (FASTACT-2): a randomised, double-blind trial

TitleIntercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-lung cancer (FASTACT-2): a randomised, double-blind trial
Authors
Issue Date2013
PublisherScience Direct.
Citation
Lancet Oncology, 2013, v. 14, p. 777-786 How to Cite?
AbstractBACKGROUND: The results of FASTACT, a randomised, placebo-controlled, phase 2 study, showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival (PFS) in patients with advanced non-small-cell lung cancer. We undertook FASTACT-2, a phase 3 study in a similar patient population. METHODS: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00883779. FINDINGS: From April 29, 2009, to Sept 9, 2010, 451 patients were randomly assigned to chemotherapy plus erlotinib (n=226) or chemotherapy plus placebo (n=225). PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo (median PFS 7·6 months [95% CI 7·2-8·3], vs 6·0 months [5·6-7·1], hazard ratio [HR] 0·57 [0·47-0·69]; p<0·0001). Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months (16·3-20·8) and 15·2 months (12·7-17·5), respectively (HR 0·79 [0·64-0·99]; p=0·0420). Treatment benefit was noted only in patients with an activating EGFR gene mutation (median PFS 16·8 months [12·9-20·4] vs 6·9 months [5·3-7·6], HR 0·25 [0·16-0·39]; p<0·0001; median overall survival 31·4 months [22·2-undefined], vs 20·6 months [14·2-26·9], HR 0·48 [0·27-0·84]; p=0·0092). Serious adverse events were reported by 76 (34%) of 222 patients in the chemotherapy plus placebo group and 69 (31%) of 226 in the chemotherapy plus erlotinib group. The most common grade 3 or greater adverse events were neutropenia (65 [29%] patients and 55 [25%], respectively), thrombocytopenia (32 [14%] and 31 [14%], respectively), and anaemia (26 [12%] and 21 [9%], respectively). INTERPRETATION: Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status.
Persistent Identifierhttp://hdl.handle.net/10722/194674
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorWu, YLen_US
dc.contributor.authorLee, JSen_US
dc.contributor.authorThongprasert, Sen_US
dc.contributor.authorYu, CJen_US
dc.contributor.authorZhang, Len_US
dc.contributor.authorLadrera, Gen_US
dc.contributor.authorSrimuninnimit, Ven_US
dc.contributor.authorSriuranpong, Ven_US
dc.contributor.authorSandoval-Tan, Jen_US
dc.contributor.authorZhu, Yen_US
dc.contributor.authorLiao, Men_US
dc.contributor.authorZhou, Cen_US
dc.contributor.authorPan, Hen_US
dc.contributor.authorLee, VHFen_US
dc.contributor.authorChen, YMen_US
dc.contributor.authorSun, Yen_US
dc.contributor.authorMargono, Ben_US
dc.contributor.authorFuerte, Fen_US
dc.contributor.authorChang, GCen_US
dc.contributor.authorSeetalarom, Ken_US
dc.contributor.authorWang, Jen_US
dc.contributor.authorCheng, CKen_US
dc.contributor.authorSyahruddin, Een_US
dc.contributor.authorQian, Xen_US
dc.contributor.authorHo, JCMen_US
dc.contributor.authorKurnianda, Jen_US
dc.contributor.authorLiu, HEen_US
dc.contributor.authorJin, Ken_US
dc.contributor.authorTruman, Men_US
dc.contributor.authorBara, Ien_US
dc.contributor.authorMok, Ten_US
dc.date.accessioned2014-02-17T02:02:57Z-
dc.date.available2014-02-17T02:02:57Z-
dc.date.issued2013en_US
dc.identifier.citationLancet Oncology, 2013, v. 14, p. 777-786en_US
dc.identifier.urihttp://hdl.handle.net/10722/194674-
dc.description.abstractBACKGROUND: The results of FASTACT, a randomised, placebo-controlled, phase 2 study, showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival (PFS) in patients with advanced non-small-cell lung cancer. We undertook FASTACT-2, a phase 3 study in a similar patient population. METHODS: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00883779. FINDINGS: From April 29, 2009, to Sept 9, 2010, 451 patients were randomly assigned to chemotherapy plus erlotinib (n=226) or chemotherapy plus placebo (n=225). PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo (median PFS 7·6 months [95% CI 7·2-8·3], vs 6·0 months [5·6-7·1], hazard ratio [HR] 0·57 [0·47-0·69]; p<0·0001). Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months (16·3-20·8) and 15·2 months (12·7-17·5), respectively (HR 0·79 [0·64-0·99]; p=0·0420). Treatment benefit was noted only in patients with an activating EGFR gene mutation (median PFS 16·8 months [12·9-20·4] vs 6·9 months [5·3-7·6], HR 0·25 [0·16-0·39]; p<0·0001; median overall survival 31·4 months [22·2-undefined], vs 20·6 months [14·2-26·9], HR 0·48 [0·27-0·84]; p=0·0092). Serious adverse events were reported by 76 (34%) of 222 patients in the chemotherapy plus placebo group and 69 (31%) of 226 in the chemotherapy plus erlotinib group. The most common grade 3 or greater adverse events were neutropenia (65 [29%] patients and 55 [25%], respectively), thrombocytopenia (32 [14%] and 31 [14%], respectively), and anaemia (26 [12%] and 21 [9%], respectively). INTERPRETATION: Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status.en_US
dc.languageengen_US
dc.publisherScience Direct.en_US
dc.relation.ispartofLancet Oncologyen_US
dc.titleIntercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-lung cancer (FASTACT-2): a randomised, double-blind trialen_US
dc.typeArticleen_US
dc.identifier.emailLee, VHF: vhflee@hku.hken_US
dc.identifier.emailCheng, CK: chengck@hkucc.hku.hken_US
dc.identifier.emailHo, JCM: jhocm@hku.hken_US
dc.identifier.authorityLee, VHF=rp00264en_US
dc.identifier.authorityHo, JCM=rp00258en_US
dc.identifier.doi10.1016/S1470-2045(13)70254-7en_US
dc.identifier.pmid23782814-
dc.identifier.hkuros227698en_US
dc.identifier.volume14en_US
dc.identifier.spage777en_US
dc.identifier.epage786en_US
dc.identifier.isiWOS:000321489800050-

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