| General information |
| Database: | DB00334 |
| Objective: | As the EGFR directed antibody cetuximab has shown activity concurrent with radiotherapy in squamous cell carcinoma of the head and neck, as well as in stage IV non small cell lung cancer combined with chemotherapy, they wanted to investigate radiotherapy with concurrent cetuximab in locally advanced non small cell lung cancer, a tumour type often over expressing the EGFreceptor. |
| Authors: | Hallqvist A, et al |
| Title: | Concurrent cetuximab and radiotherapy after docetaxelcisplatin induction chemotherapy in stage III non small cell lung cancer: satellitea phase II study from the Stheydish Lung Cancer Study Group. |
| Journal: | Lung Cancer. |
| Year: | 2011 |
| PMID: | 20541833 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | Concurrent cetuximab + radiotherapy(after)+ docetaxelcisplatin induction chemotherapy(before) |
| Study Type: | Satellite¡ªa phase II study |
| Key Patients Feature: | histologically or cytologicallyverified non small cell lung cancer Stage IIIA/IIIB, medically inoperable or unresectabletumours, PS WHO 0-1, FEV1 more than and equal to 1 L or more than and equal to 40% of expected volume, no prior chemotherapy or radiation therapy for non small cell lung cancer, adequate bone marrow reserve, age more than and equal to 18 years, no upper age limit |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of 2 cycles of induction chemotherapy, docetaxel 75 mg/m2 and cisplatin 75 mg/m2 with 3 weeks interval. An initial dose of cetuximab 400 mg/m2 was given before start of 3DCRT to 68 Gy with 2 Gy per fraction in 7 weeks concurrent with weekly cetuximab 250 mg/m2. TOXICITY was scored weekly during radiotherapy (CTC 3.0), and after treatment the patients were followed every third month with CTscans, toxicity scoring and QLQ. |
| Primary End Point: | clinical benefit at 12 months, defined as CR + PR + SD. |
| Secondary End Point: | overall survival, response rate, toxicity, relapse pattern, quality of life measured with EORTC QLQ 30 + LC 14, as well as possible universal prognostic factors for survival and predictive factors for clinical response. |
| Patients Number: | 75 |
| Trial Results |
| DLT_MTD: | Toxicity:esophagitis grade 1-2: 72%; grade 3: 1.4%. Hypersensitivity reactions grade 3-4: 5.6%. Febrile neutropeniagrade 3-4: 15.4%. Skin reactions grade 1-2: 74%; grade 3: 4.2%. Diarrhoea grade 1-2: 38%; grade 3:11.3%. Pneumonitis grade 1-2: 26.8%; grade 3: 4.2%; grade 5: 1.4%. |
| Objective Response Rate: | clinical benefit at 12 months(CR + PR + SD) was evaluated by CTscans, and was 30% (95%CI: 19-40%). The majority had partial response (15.5%) with 7%each in the complete response and stable disease groups. Theresponse rates after two cycles of induction chemotherapy were29% (95% CI: 19-40%) PR, 67% (95% CI: 55-77%) SD, 3% PD and 1%NE |
| Disease Control Rate: | 0.99 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | the median survival was 17 months with a 1, 2 and 3year OS of 66%, 37% and 29% respectively. |
| Adverse Event(agent arm): | esophagitis grade 1-2: 72%; grade 3: 1.4%. Hypersensitivity reactions grade 3-4: 5.6%. Febrile neutropenia grade 3-4: 15.4%. Skin reactions grade 1-2: 74%; grade 3: 4.2%. Diarrhoea grade 1-2: 38%; grade 3: 11.3%. Pneumonitis grade 1-2: 26.8%; grade 3: 4.2%; grade 5: 1.4%. |
| Conclusions: | Induction chemotherapy followed by concurrent cetuximab and RT to 68 Gy is clearly feasible with promising survival. TOXICITY, e.g. pneumonitis and esophagitis is low compared to most schedules with concurrent chemotherapy. This treatment strategy should be evaluated in a randomised manner vs. concurrent chemoradiotherapy to find out if it is a valid treatment option. |