Randomized phase II study of amifostine mucosal protection by either subcutaneous injection or rapid IV bolus for patients with inoperable stage II-IIIA/B or stage IV non-small cell lung cancer with oligometastases receiving concurrent radiochemotherapy with carboplatin and paclitaxel followed by optional consolidative chemotherapy: a follow-up study after RTOG 98-01.
While concurrent chemoradiotherapy is a standard treatment for good-performance patients with non-small cell lung cancer, acute esophagitis is a frequent toxicity. The incidence of severe acute esophagitis > or = grade 3 in patients treated with standard (once-daily) radiation therapy alone is 1.3%, increasing to 14% to 25% with the addition of concurrent chemotherapy, and 24% to 34% for the combination of hyperfractionated (twice-daily) radiation therapy plus concomitant chemotherapy. Although esophagitis is almost never a cause of mortality, it results in significant morbidity and may force treatment breaks, which are associated with inferior outcome in non-small cell lung cancer. Substantial investigative efforts to prevent or ameliorate esophagitis have been conducted. We describe herein the rationale/study design for a multi-institutional, phase II randomized study to evaluate either daily subcutaneous or intravenous bolus infusions of amifostine in patients with non-small cell lung cancer who receive standard fractionated thoracic radiation therapy concurrently with weekly paclitaxel and carboplatin chemotherapy.
Werner-Wasik
Maria
M
Kimmel Cancer Center of Jefferson Medical College, Philadelphia, PA 19107, USA. maria.werner-wasik@mail.tju.edu
Langer
Corey
C
Movsas
Benjamin
B
D004999:Amifostine / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D009092:Mucous Membrane / Q000528:radiation effects; D011837:Radiation-Protective Agents / Q000627:therapeutic use*
D011837:Radiation-Protective Agents; D016190:Carboplatin; D004999:Amifostine