Tummarello D, Graziano F, Isidori P, Cellerino R
Department of Medical Oncology, Ospedale di Torrette, University of Ancona, Italy.
Cancer Chemother Pharmacol. 1995;35(3):249-53. doi: 10.1007/BF00686556.
In a series of 46 symptomatic patients with metastatic, stage IV, non-small-cell lung cancer (NSCLC), we used a three-drug combination with cisplatin (120 mg/m2), vinblastine (6 mg/m2) and mitomycin-C (6 mg/m2) (PVM), repeated every 3 weeks. After two courses, we observed that none of the patients had achieved a complete response; 33% (15/46) had partial response (95% confidence limits: 19.2-46.8); 39% (18/46), stable disease and 28% (13/46), progressive disease. Median response duration was 14.0 weeks (range, 4-36.7), median time to progression 22.4 weeks (range, 7-44.4), and median survival time 26.4 weeks (range, 1-103). WHO grade III-IV myelotoxicity occurred in 15.2% of the courses administered, affecting 39.5% of patients, and severe nephrotoxicity was observed in 9.3% of patients. No toxic death occurred. The post-treatment KPS score increased in 7 patients with partial response (47%), 4 with stable disease (22%) and 1 with progressive disease (8%), while it decreased in 3 patients with partial response (20%), 3 with stable disease (17%) and 10 with progressive disease (77%). In all, KPS increased in 12/46 cases (26%). However, no statistically significant difference was observed when the KPS score before and after treatment was compared in the total group of patients or when it was compared in the total group of patients or when it was compared in responders and in non-responders. After chemotherapy, there was complete disappearance of at least one symptom in 27.1% of cases and improvement in 27.1%. Overall, major symptom control occurred in 54.3% of cases, with a median palliation time lasting 10 weeks (range, 4-32). Patients with partial remission and stable disease achieved symptomatic palliation in 90% and 55.5% of cases, respectively. When we compared the palliation rate between responders and non-responders, a significant difference was noted (Chi-square test: P < 0.05). Although our schedule did not produce a higher objective response rate and the KPS score was not significantly improved, the symptom palliation appeared worthwhile considering the highly unfavourable prognosis of the patients investigated.
在一组46例有症状的转移性IV期非小细胞肺癌(NSCLC)患者中,我们采用了顺铂(120mg/m²)、长春碱(6mg/m²)和丝裂霉素-C(6mg/m²)的三联药物组合(PVM),每3周重复一次。两个疗程后,我们观察到没有患者达到完全缓解;33%(15/46)有部分缓解(95%置信区间:19.2 - 46.8);39%(18/46)为疾病稳定,28%(13/46)为疾病进展。中位缓解持续时间为14.0周(范围4 - 36.7),中位疾病进展时间为22.4周(范围7 - 44.4),中位生存时间为26.4周(范围1 - 103)。在给药的疗程中,15.2%出现WHO III - IV级骨髓毒性,影响39.5%的患者,9.3%的患者观察到严重肾毒性。未发生毒性死亡。部分缓解的7例患者(47%)、疾病稳定的4例患者(22%)和疾病进展的1例患者(8%)治疗后KPS评分升高,而部分缓解的3例患者(20%)、疾病稳定的3例患者(17%)和疾病进展的10例患者(77%)KPS评分降低。总体而言,46例中有12例(26%)KPS升高。然而,在患者总体组中比较治疗前后的KPS评分时,或在反应者和无反应者中进行比较时,均未观察到统计学上的显著差异。化疗后,27.1%的病例至少一种症状完全消失,27.1%有所改善。总体而言,54.3%的病例实现了主要症状控制,中位缓解时间持续10周(范围4 - 32)。部分缓解和疾病稳定的患者分别在90%和55.5%的病例中实现了症状缓解。当我们比较反应者和无反应者之间的缓解率时,发现有显著差异(卡方检验:P < 0.05)。尽管我们的方案未产生更高的客观缓解率,且KPS评分未显著改善,但考虑到所研究患者的高度不良预后,症状缓解似乎是值得的。