Urinary-derived Monocyte-Colony Stimulating Factor (P-100) following treatment with carboplatin and etoposide in small cell lung cancer (SCLC)

• Published in: Annals of oncology 1993-12, Vol.4 (10), p.877-881
• Main Authors: Van Hoef, M. E. H. M., Radford, J. A., Jones, A., Smith, I. E., Earl, H. M., Woll, P. J., Thatcher, N.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; carboplatin; Carboplatin - administration & dosage; Carcinoma, Small Cell - mortality; Carcinoma, Small Cell - therapy; Drug toxicity and drugs side effects treatment; etoposide; Etoposide - administration & dosage; Female; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects; Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local; P-100; Pharmacology. Drug treatments; Remission Induction; SCLC; Survival Rate; Toxicity: blood; Treatment Outcome; urinary-derived Monocyte-Colony Stimulating Factor
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/oxfordjournals.annonc.a058397

Background: The hematopoietic growth factor P-100 is a monocyte-colony stimulating factor purified from human urine and has been reported to reduce neutropenia following chemotherapy. In this study the effect and toxicity of P-100 was evaluated in 26 patients receiving intensive chemotherapy for SCLC. Study design: Chemotherapy consisted of four 28 day cycles of carboplatin (C) 600 mg/m2 i.v. on day 1 of cycle 1 + 2 and 300 mg/m2 i.v. on day 1 of cycle 3 + 4 and etoposide (E) 120 mg/m2 i.v. on day 1–3 of each cycle. Patients were randomised to receive P-100 for ten days following chemotherapy during either the first or second cycle. 12 Patients received P-100 with the first and 12 with the second cycle. For each group cycles with P-100 were compared to cycles without P-100. Results: P-100 was well tolerated but no significant differences between cycles with and without P-100 were seen in the administered chemotherapy dose, depth and duration of neutropenia, number of blood or platelet transfusions, WHO grade 3–4 infection or requirement for intravenous antibiotics. Of 24 evaluable patients 14 (58.3%) achieved CR and 4 (16.6%) PR. Patients achieving CR received radiotherapy. The median time to progression was 169 days (range 38–995+ days) and the median survival time was 305 days (range 42–1052+ days). Three patients are alive after 2 years (11.5%), 2 without relapse (7.7%). Alopecia, nausea and vomiting occurred in all patients but no treatment related deaths occurred. Conclusion: In this study P-100 did not significantly influence the myelotoxicity associated with carboplatin-etoposide chemotherapy in the treatment of SCLC.