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A randomized study of chemotherapy with cisplatin plus etoposide versus chemoendocrine therapy with cisplatin, etoposide and the pineal hormone melatonin as a first-line treatment of advanced non-small cell lung cancer patients in a poor clinical state.
J Pineal Res 1997; 23(1):15-9JP

Abstract

Recent studies suggest that the pineal hormone melatonin may reduce chemotherapy-induced immune and bone marrow damage. In addition, melatonin may exert potential oncostatic effects either by stimulating host anticancer immune defenses or by inhibiting tumor growth factor production. On this basis, we have performed a randomized study of chemotherapy alone vs. chemotherapy plus melatonin in advanced non-small cell lung cancer patients (NSCLC) with poor clinical status. The study included 70 consecutive advanced NSCLC patients who were randomized to receive chemotherapy alone with cisplatin (20 mg/m2/day i.v. for 3 days) and etoposide (100 mg/m2/day i.v. for 3 days) or chemotherapy plus melatonin (20 mg/day orally in the evening). Cycles were repeated at 21-day intervals. Clinical response and toxicity were evaluated according to World Health Organization criteria. A complete response (CR) was achieved in 1/34 patients concomitantly treated with melatonin and in none of the patients receiving chemotherapy alone. Partial response (PR) occurred in 10/34 and in 6/36 patients treated with or without melatonin, respectively. Thus, the tumor response rate was higher in patients receiving melatonin (11/34 vs. 6/35), without, however, statistically significant differences. The percent of 1-year survival was significantly higher in patients treated with melatonin plus chemotherapy than in those who received chemotherapy alone (15/34 vs. 7/36, P < 0.05). Finally, chemotherapy was well tolerated in patients receiving melatonin, and in particular the frequency of myelosuppression, neuropathy, and cachexia was significantly lower in the melatonin group. This study shows that the concomitant administration of melatonin may improve the efficacy of chemotherapy, mainly in terms of survival time, and reduce chemotherapeutic toxicity in advanced NSCLC, at least in patients in poor clinical condition.

Authors+Show Affiliations

Divisione di Radioterapia Oncologica, Ospedale S, Gerardo, Monza, Milan, Italy.

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9379341

Citation

Lissoni, P, et al. "A Randomized Study of Chemotherapy With Cisplatin Plus Etoposide Versus Chemoendocrine Therapy With Cisplatin, Etoposide and the Pineal Hormone Melatonin as a First-line Treatment of Advanced Non-small Cell Lung Cancer Patients in a Poor Clinical State." Journal of Pineal Research, vol. 23, no. 1, 1997, pp. 15-9.
Lissoni P, Paolorossi F, Ardizzoia A, et al. A randomized study of chemotherapy with cisplatin plus etoposide versus chemoendocrine therapy with cisplatin, etoposide and the pineal hormone melatonin as a first-line treatment of advanced non-small cell lung cancer patients in a poor clinical state. J Pineal Res. 1997;23(1):15-9.
Lissoni, P., Paolorossi, F., Ardizzoia, A., Barni, S., Chilelli, M., Mancuso, M., ... Maestroni, G. J. (1997). A randomized study of chemotherapy with cisplatin plus etoposide versus chemoendocrine therapy with cisplatin, etoposide and the pineal hormone melatonin as a first-line treatment of advanced non-small cell lung cancer patients in a poor clinical state. Journal of Pineal Research, 23(1), pp. 15-9.
Lissoni P, et al. A Randomized Study of Chemotherapy With Cisplatin Plus Etoposide Versus Chemoendocrine Therapy With Cisplatin, Etoposide and the Pineal Hormone Melatonin as a First-line Treatment of Advanced Non-small Cell Lung Cancer Patients in a Poor Clinical State. J Pineal Res. 1997;23(1):15-9. PubMed PMID: 9379341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized study of chemotherapy with cisplatin plus etoposide versus chemoendocrine therapy with cisplatin, etoposide and the pineal hormone melatonin as a first-line treatment of advanced non-small cell lung cancer patients in a poor clinical state. AU - Lissoni,P, AU - Paolorossi,F, AU - Ardizzoia,A, AU - Barni,S, AU - Chilelli,M, AU - Mancuso,M, AU - Tancini,G, AU - Conti,A, AU - Maestroni,G J, PY - 1997/8/1/pubmed PY - 1997/10/23/medline PY - 1997/8/1/entrez SP - 15 EP - 9 JF - Journal of pineal research JO - J. Pineal Res. VL - 23 IS - 1 N2 - Recent studies suggest that the pineal hormone melatonin may reduce chemotherapy-induced immune and bone marrow damage. In addition, melatonin may exert potential oncostatic effects either by stimulating host anticancer immune defenses or by inhibiting tumor growth factor production. On this basis, we have performed a randomized study of chemotherapy alone vs. chemotherapy plus melatonin in advanced non-small cell lung cancer patients (NSCLC) with poor clinical status. The study included 70 consecutive advanced NSCLC patients who were randomized to receive chemotherapy alone with cisplatin (20 mg/m2/day i.v. for 3 days) and etoposide (100 mg/m2/day i.v. for 3 days) or chemotherapy plus melatonin (20 mg/day orally in the evening). Cycles were repeated at 21-day intervals. Clinical response and toxicity were evaluated according to World Health Organization criteria. A complete response (CR) was achieved in 1/34 patients concomitantly treated with melatonin and in none of the patients receiving chemotherapy alone. Partial response (PR) occurred in 10/34 and in 6/36 patients treated with or without melatonin, respectively. Thus, the tumor response rate was higher in patients receiving melatonin (11/34 vs. 6/35), without, however, statistically significant differences. The percent of 1-year survival was significantly higher in patients treated with melatonin plus chemotherapy than in those who received chemotherapy alone (15/34 vs. 7/36, P < 0.05). Finally, chemotherapy was well tolerated in patients receiving melatonin, and in particular the frequency of myelosuppression, neuropathy, and cachexia was significantly lower in the melatonin group. This study shows that the concomitant administration of melatonin may improve the efficacy of chemotherapy, mainly in terms of survival time, and reduce chemotherapeutic toxicity in advanced NSCLC, at least in patients in poor clinical condition. SN - 0742-3098 UR - https://www.unboundmedicine.com/medline/citation/9379341/A_randomized_study_of_chemotherapy_with_cisplatin_plus_etoposide_versus_chemoendocrine_therapy_with_cisplatin_etoposide_and_the_pineal_hormone_melatonin_as_a_first_line_treatment_of_advanced_non_small_cell_lung_cancer_patients_in_a_poor_clinical_state_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0742-3098&amp;date=1997&amp;volume=23&amp;issue=1&amp;spage=15 DB - PRIME DP - Unbound Medicine ER -