| General information |
| Database: | DB00746 |
| Objective: | The epidermal growth factor receptor (EGFR) tyrosinekinase inhibitor erlotinib is associated with survival benefits in patients with EGFR mutationpositive non small cell lung cancer (non small cell lung cancer). Thisphase II, singlearm study examined the efficacy and safety of firstline erlotinib in Japanese patients with EGFR mutationpositive non small cell lung cancer. |
| Authors: | Goto K, et al |
| Title: | A prospective, phase II, openlabel study (JO22903) of firstline erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutationpositive advanced non small cell lung cancer (non small cell lung cancer). |
| Journal: | Lung Cancer. |
| Year: | 2013 |
| PMID: | 23910906 |
| Trial Design |
| Clinical Trial Id: | CTI101085 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | (EGFR) mutationpositive advanced non small cell lung cancer (non small cell lung cancer) |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A prospective, phase II, openlabel study (JOIIII90III) |
| Key Patients Feature: | Eligible patients were aged more than and equal to 20 years with advanced, untreated, metastatic (stage IIIB/IV), or relapsed non small cell lung cancer, with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 and tumors harboring confirmed activating mutations of EGFR (exon 19 deletion or L858R point mutation in exon 21), with at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Staging was assessed by TNM classification (7th edition). |
| Biomarker: | epidermal growth factor receptor (EGFR) mutationpositive |
| Biomark Analysis: | Exon 19 deletions seemed to be associated with longer PFS compared with L858R mutations; T790M mutations were tentatively linked with shorter PFS. |
| Control Group Info: | single arm |
| Treatment Info: | Eligible patients received erlotinib 150 mg/day until disease progression or unacceptable toxicity. |
| Primary End Point: | progression free survival (PFS) and safety. |
| Secondary End Point: | NA |
| Patients Number: | 102 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 78% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.8 months (95% confidence interval [CI]: 9.715.3) |
| Median OS A vs. C: | The 1year eventfree survival rate was 49% (95% CI: 39-59) |
| Adverse Event(agent arm): | A total of 43 patients required dose modification due to AEs of grade more than and equal to 2, the majority of which were skin toxicities (n = 22). Ten patients (10%) discontinued erlotinib due to AEs: ILD or ILDlike events (n = 6), abnormal liver function or liver enzyme levels (n = 3), and skin rash (n = 1). |
| Conclusions: | Erlotinib should be considered for firstline treatment in this subset of Japanese patients, with close monitoring for ILDlike events. |