Sequential Vinorelbine and Docetaxel in Advanced Non-small Cell Lung Cancer Patients Age 70 and Older and/or with a Performance Status of 2: A Phase II Trial of the Southwest Oncology Group (S0027)

Context Clinical trials utilize clinician-graded adverse events (AEs) and patient-reported outcomes (PROs) to describe symptoms. Objectives To examine the agreement between PROs and AEs in the clinical trial setting. Methods Patient-level data were pooled from seven North Central Cancer Treatment Group, two Southwest Oncology Group and three Radiation Therapy Oncology Group lung studies that included both PROs and AE data. Ten-point changes (on a 0–100 scale) in PRO scores were considered clinically significant differences (CSDs). PRO score changes were compared to AE grade (Gr) categories (2+ yes vs. no and 3+ yes vs. no) using Wilcoxon rank-sum or two-sample t-tests between Gr categories. Incidence rates and concordance of CSD in PRO scores and AE grade categories were compiled. Spearman correlations were computed between PRO scores and AE severity. Results PROs completed by patients (N=1013) were the Uniscale, Lung Cancer Symptom Scale (LCSS), Functional Assessment of Cancer Therapy-Lung (FACT-L), Symptom Distress Scale (SDS), and/or Functional Living Index-Cancer (FLIC). Significantly worse PRO score changes were found for the FACT-L in patients with Gr 2+ AEs. Worse scores were seen for the Uniscale for patients with grade 2+ AEs (P=0.07) and LCSS for patients with Gr 3+ AEs (P=0.09). Agreement between incidence of any Gr 2+(Gr 3+) AE and a CSD in PROs ranged from 27%–67% (36%–61%). Correlations between PRO scores and AE severity were low: −0.06 Uniscale, −0.03 LCSS, 0.10 FACT-L, −0.11 SDS and −0.51 FLIC. Conclusion These results support previous work and an a priori hypothesis that AEs and PROs measure differing aspects of the disease experience and are complementary.

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First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Tibaldi¹,

Vasile²,

Antonuzzo

et al. 2008

Br J Cancer

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This multicenter phase II study evaluated, in chemonaive patients with stage IIIB -IV NSCLC, age X70 and with a performance status 0 -2, the activity, efficacy and tolerability of planned sequential administration of gemcitabine 1200 mg m À2 on days 1 and 8 every 3 weeks for three courses followed by three cycles of docetaxel 37.5 mg m À2 on days 1 and 8 every 3 weeks, provided there was no evidence of disease progression. A total of 56 patients entered the study. According to intention-to-treat analysis, the objective response rate was 16.0% (95% CI 7.6 -28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of gemcitabine obtained a conversion to partial response by docetaxel. Median time to progression was 4.8 months (95% CI 3.6 -6.0 months) and median duration of survival was 8.0 months (95% CI 5.6 -10.5 months). The 1-year survival rate was 34%. No grade 4 haematological toxicity was observed and grade 3 neutropenia and thrombocytopenia were reported in 5.4 and 3.6% of the patients, respectively. Grade 3/4 mucositis and grade 3 diarrhoea, both occurred in 3.6% of the patients and grade 3 asthenia was observed in 9% of patients. One patient reported a grade 4 skin toxicity. No treatment-related deaths occurred. Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.

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Sequential Vinorelbine and Docetaxel in Advanced Non-small Cell Lung Cancer Patients Age 70 and Older and/or with a Performance Status of 2: A Phase II Trial of the Southwest Oncology Group (S0027)

Cited by 11 publications

References 48 publications

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What is an “Elderly” oncologic patient?

The Complementary Nature of Patient-Reported Outcomes and Adverse Event Reporting in Cooperative Group Oncology Clinical Trials: A Pooled Analysis (NCCTG N0591)

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

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