Lissoni P, Paolorossi F, Ardizzoia A, Barni S, Chilelli M, Mancuso M, Tancini G, Conti A, Maestroni G J
Divisione di Radioterapia Oncologica, Ospedale S, Gerardo, Monza, Milan, Italy.
J Pineal Res. 1997 Aug;23(1):15-9. doi: 10.1111/j.1600-079x.1997.tb00329.x.
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.
近期研究表明，松果体激素褪黑素可能会减轻化疗引起的免疫和骨髓损伤。此外，褪黑素可能通过刺激宿主抗癌免疫防御或抑制肿瘤生长因子的产生发挥潜在的抑癌作用。在此基础上，我们对临床状况较差的晚期非小细胞肺癌（NSCLC）患者进行了一项单独化疗与化疗加褪黑素的随机研究。该研究纳入了70例连续的晚期NSCLC患者，他们被随机分为两组，一组接受顺铂（20mg/m²/天，静脉注射3天）和依托泊苷（100mg/m²/天，静脉注射3天）的单独化疗，另一组接受化疗加褪黑素（每晚口服20mg）。每21天重复一个周期。根据世界卫生组织标准评估临床反应和毒性。接受褪黑素联合治疗的34例患者中有1例达到完全缓解（CR），而单独接受化疗的患者中无一例达到。部分缓解（PR）分别发生在接受或未接受褪黑素治疗的34例患者中的10例和36例患者中的6例。因此，接受褪黑素治疗的患者肿瘤缓解率更高（11/34 vs. 6/35），然而，差异无统计学意义。接受褪黑素加化疗的患者1年生存率百分比显著高于单独接受化疗的患者（15/34 vs. 7/36，P<0.05）。最后，接受褪黑素治疗的患者对化疗耐受性良好，特别是褪黑素组中骨髓抑制、神经病变和恶病质的发生率显著更低。这项研究表明，联合使用褪黑素可能会提高化疗疗效，主要体现在生存时间方面，并降低晚期NSCLC患者的化疗毒性，至少对于临床状况较差的患者如此。
