| General information |
| Database: | DB00404 |
| Objective: | To investigate the feasibility and efficacy of concurrent chemoradiation in combination with erlotinib for locally advanced esophageal carcinoma. |
| Authors: | Li G, et al |
| Title: | Phase II study of concurrent chemoradiation in combination with erlotinib for locally advanced esophageal carcinoma. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2009 |
| PMID: | 20350790 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | esophagealsquamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | concurrent chemoradiation + erlotinib |
| Study Type: | PHASE II STUDY |
| Key Patients Feature: | patients were clinically staged T1-4 Nx, M0-1a excludingpatients with a tracheoesophageal fistula pathologically confirmed esophagealsquamous cell carcinoma patients were to be of $18 years of age with a KarnofskyPerformance Status $60. White blood cell counts had to be$3, 000/mm, platelet counts $100, 000/mm, hemoglobin $10 g%, serum creatinine at or less than the institutional upper limit ofnormal, and/or creatinine clearance $50 cc/min. Patients must nothave had a second malignancy, other than curable nonmelanomaskin cancer or cervical cancer in situ, unless they were disease freefor $5 years. No prior chest radiation or chemotherapy was allowed. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with concurrent chemoradiotherapy. A daily fraction of 2.0 Gy was prescribed to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135 mg/m(2), d(1)) and cisplatin (20 mg/m(2), d(13)) were administered on Day 1 and Day 29 of the radiotherapy. Erlotinib, an oral epidermal growth factor receptortyrosine kinase inhibitor, was taken by every patient at the dose of 150 mg daily during the chemoradiotherapy. |
| Primary End Point: | localregional control survival and overall survival. |
| Secondary End Point: | response rate, toxicity and tolerability. |
| Patients Number: | 24 |
| Trial Results |
| DLT_MTD: | During the chemoradiotheapy, the incidences of acutetoxicities of Grade 3 or greater, such as leucopenia and thrombocytopenia, were 16.7 % (4/24) and 8.3% (2/24). |
| Objective Response Rate: | The median followup of the 24 patients was 18.6 months (range, 7.1-29.6 months). The 2year overallsurvival, localregional control, and relapsefree survival were 70.1% (95% CI, 50.4-90%), 87.5% (95% CI, 73.5-100%), and 57.4% (95% CI, 36.3-78.7%), respectively |
| Disease Control Rate: | 0.916 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2year diseasefree survival was 57.4% (95% CI, 36.2-78.7%) |
| Median OS A vs. C: | The 2year overall survival rate is 70.1% (95% CI, 50.4-90%) |
| Adverse Event(agent arm): | During the chemoradiotheapy, the incidences of acute toxicities of Grade 3 or greater, such as leucopenia and thrombocytopenia, were 16.7 % (4/24) and 8.3% (2/24). |
| Conclusions: | Application of concurrent chemoradiotherapy in combination with erlotinib for locally advanced esophageal carcinoma yielded satisfactory 2year overall survival and localregional control. The toxicities they were well tolerated. |