Han, Hye-Suk; Han, Ji-Youn; Yu, Sun Young; Pyo, Hong Ryull; Kim, Hyae Young; Cho, Kwan Ho; Lee, Dae Ho; Kim, Heung Tae; Lee, Jin Soo
Cancer
2008Oct ; 113 ( 7 ) :1623-31.
PMID : 18671241
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Han, Hye-Suk -
Han, Ji-Youn -
Yu, Sun Young -
Pyo, Hong Ryull -
Kim, Hyae Young -
Cho, Kwan Ho -
Lee, Dae Ho -
Kim, Heung Tae -
Lee, Jin Soo -
ABSTRACT
BACKGROUND: The purpose of the current study was to investigate the role of amifostine and epoetin-alpha in reducing severe toxicities during concurrent chemo-hyperfractionated radiotherapy (CCRT) for limited disease small cell lung cancer (LD-SCLC).
METHODS: Seventy-six patients with LD-SCLC were enrolled. The treatment schedule was consisted of two 28-day cycles of cisplatin at a dose of 30 mg/m2 (Days 1 and 8) and irinotecan at a dose of 60 mg/m2 (Days 1, 8, and 15) followed by two 21-day cycles of cisplatin at a dose of 60 mg/m2 (Day 1) and etoposide at a dose of 100 mg/m2 (Days 1-3) with concurrent twice-daily thoracic radiotherapy for a total of 45 grays. Patients were randomly assigned at registration to either amifostine at a dose of 500 mg or epoetin-alpha at a dose of 10,000 IU subcutaneously 3 times weekly (n = 36 patients and 40 patients, respectively). Fifteen of 36 patients assigned to the amifostine arm did not receive amifostine because of a lack of supply.
RESULTS: Amifostine treatment was associated with higher febrile neutropenia (P = .003) and grade 2 or 3 nausea (according to the National Cancer Institute Common Toxicity Criteria [version 3.0]) (P = .03). It also demonstrated a trend toward higher grade 4 leukopenia (P = .05). Grade 3 esophagitis was reported in 30% of patients treated with amifostine and 9% of patients treated with epoetin-alpha (P = .059). Epoetin-alpha treatment was associated with less grade 2 or 3 anemia (P = .031) and lower decreases in hemoglobin level during CCRT (P = .016). The median survival times for both treatment arms were comparable (22.6 months in the amifostine arm vs 25.6 months in the epoetin-alpha arm; P = .447).
CONCLUSIONS: Although amifostine administered 3 times weekly during CCRT did not significantly reduce severe toxicities, epoetin-alpha was effective in preventing severe anemia during CCRT in patients with LD-SCLC. Other radioprotective strategies to minimize severe toxicities should be investigated.
amifostine, epoetin-a, concurrent chemoradiotherapy, small cell lung cancer
MESH
Aged, Amifostine/*administration & dosage, Antineoplastic Agents/adverse effects, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Carcinoma, Small Cell/*drug therapy/*radiotherapy, Combined Modality Therapy, Dose Fractionation, Drug Administration Schedule, Epoetin Alfa, Erythropoietin/*administration & dosage, Female, Humans, Injections, Subcutaneous, Lung Neoplasms/*drug therapy/*radiotherapy, Male, Middle Aged, Radiation-Protective Agents/*administration & dosage, Recombinant Proteins, Survival Analysis
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