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In Reply

Osaka City University Medical School, Asahimachi, Abeno-ku,Osaka, Japan

Gridelli et al raise four questions in their letter that comments on our article.¹ The dose of vinorelbine 25 mg/m² on days 1 and 8 every 3 weeks was low. In the United States and European countries, vinorelbine monotherapy was administered weekly 30 mg/m² in patients with non–small-cell lung cancer (NSCLC).² In Japan, the vinorelbine was approved for a weekly schedule at a dose of 25 mg/m².³ In our study, we reduced the dose from weekly administration to days 1 and 8 every 3 weeks. Therefore, the dose-intensity was reduced from 25 mg/m²/week to 16.67 mg/m²/week as mentioned by Gridelli et al. The Elderly Lung Cancer Vinorelbine Italian Study Group (ELVIS)⁴ and the Multicenter Italian Lung Cancer in the Elderly Study (MILES)⁵ also reduced the vinorelbine dose from 30 mg/m² to days 1 and 8 every 3 weeks and the dose-intensity was 20 mg/m²/week. We considered that it was necessary to reduce the definite dose of agents in the treatment of elderly patients. Grade 3 to 4 neutropenia was severe in our study compared with MILES⁵ (69.3% v 25%) as mentioned in our article. Compared with the Japanese vinorelbine phase II study,³ leukopenia was lower in our study (grade 3 to 4, 60.8% v 51.7%), but the incidence of anemia and constipation were higher in our study. Therefore, we consider the dose of vinorelbine in our study to be appropriate.

The slow accrual in our study was the second problem noted by Gridelli et al. These comments are almost right. In the protocol, the study period was planned for 30 months for 180 patients (six patients/month). We needed 40 months to accrue 182 patients (4.5 patients/month) as mentioned. Our study, West Japan Thoracic Oncology Group (WJTOG) 9904,¹ was the first large-scale multicenter clinical trial of elderly patients with NSCLC. Attending physicians were too careful to enroll patients because of their age. Therefore, many patients in our study had good prognostic factors including performance status and comorbidity (Table 1). Another cause that might be considered is that some members of the WJTOG did not have much interest in a clinical trial for elderly patients with NSCLC.

Finally, we agree with the discussion by Gridelli et al of the importance of comorbid health problems in elderly patients with NSCLC. The detailed comorbid illnesses were shown in Table 1. The proportion of comorbid illnesses was compared with MILES.⁵ We did not investigate the severity of comorbid illnesses and the administration of geriatric scales, which will be investigated in our next trial.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author indicated no potential conflicts of interest.

REFERENCES

1. Kudoh S, Takeda K, Nakagawa K, et al: Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non–small-cell lung cancer: Results of the West Japan Thoracic Oncology Group trial (WJTOG 9904). J Clin Oncol 24:3657-3663, 2006[Abstract/Free Full Text]

2. Le Chevalier T, Brisgand D, Douillard JY, et al: Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: Results of a European multicenter trial including 612 patients. J Clin Oncol 12:360-367, 1994[Abstract]

3. Furuse K, Kubota K, Kawahara M, et al: A phase II study of vinorelbine, a new derivative of vinca alkaloid, for previously untreated advanced non-small cell lung cancer: Japan Vinorelbine Lung Cancer Study Group. Lung Cancer 11:385-391, 1994[CrossRef][Medline]

4. The Elderly Lung Cancer Vinorelbine Italian Study Group: Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 91:66-72, 1999[Abstract/Free Full Text]

5. Gridelli C, Perrone F, Gallo C, et al: Chemotherapy for elderly patients with advanced non-small-cell lung cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 95:362-372, 2003[Abstract/Free Full Text]

6. Kurihara M, Shimizu H, Tsuboi K, et al: Development of quality of life questionnaire in Japan: Quality of life assessment of cancer patients receiving chemotherapy. Psychol Oncol 8:355-363, 1999[CrossRef]

7. Kudoh S: In reply on Ashok K, et al: J Clin Oncol 25:1144, 2007[Free Full Text]

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