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Journal of Clinical Oncology, Vol 22, No 24 (December 15), 2004: pp. 5020-5021 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.04.223
In Reply:
Memorial Sloan-Kettering Cancer Center, New York, NY Based on the data reviewed by the American Society of Clinical Oncology Expert Panel in 2003, the most important predictor of outcome from treatment with cytotoxic chemotherapy for patients with metastatic non–small-cell lung cancer (NSCLC) is performance status (PS). Patients with an Eastern Cooperative Oncology Group-Zubrod PS of 2 (ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours) or a Karnofsky PS of 60% or 70% (unable to work, able to live at home and care for most personal needs; a varying amount of assistance is needed; KPS 70%: cares for self, unable to carry on normal activity or do active work; KPS 60%: requires occasional assistance but is able to care for most of own needs) are less likely to benefit. There are sufficient data to support the use of single-agent chemotherapy over supportive care only in patients with good PS.1-3 Furthermore, there are sufficient data to conclude that combination chemotherapy is more toxic than single-agent chemotherapy, even when nonplatinum combinations are used.4 The available data fail to clearly prove that combination chemotherapy is superior to single-agent chemotherapy with regard to survival for patients with PS 2. The American Society of Clinical Oncology Expert Panel concluded that the available data in 2003 supported the use of single-agent chemotherapy in patients with metastatic NSCLC and PS 2. The data presented here by Perrone et al from a subgroup analysis of the Multicenter Italian Lung Cancer in the Elderly Study are consistent with this conclusion. However, another subgroup analysis and a recent small trial dedicated to patients with PS 2 have concluded that selected two-drug combinations may be superior to single agents.5,6 As such, the role of combination chemotherapy in the management of PS 2 patients generates debate. We agree with Perrone et al that, in a randomized clinical trial dedicated to PS 2 patients, single-agent chemotherapy is at present an appropriate control arm. This implies that, at the time of enrollment, the oncologist has already decided to treat the patient with chemotherapy. Although there are insufficient data to support the routine use of combination chemotherapy in patients with PS 2, there are clinical trials underway for PS 2 patients who use combination chemotherapy as a control arm, which was inspired by the aforementioned subgroup analysis.6,7 Deciding on the best chemotherapy for PS 2 patients remains an active area of research. The rapid advances in chemotherapy for NSCLC, including continued development of less toxic, targeted chemotherapy agents, and clinical trials dedicated to important subgroups of patients (eg, patients with PS 2 or bronchioloalveolar histology) may soon merit another update. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest. REFERENCES 1. Roszkowski K, Pluzanska A, Krzakowski M, et al: A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 27:145-157, 2000[CrossRef][Medline]
2. Ranson M, Davidson N, Nicolson M, et al: Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 92:1074-1080, 2000
3. Gridelli C: The ELVIS trial: A phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer: Elderly Lung Cancer Vinorelbine Italian Study. Oncologist 6:4-7, 2001 (suppl 1)
4. 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 5. Comella P, Frasci G, Carnicelli P, et al: Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients. Br J Cancer 91:489-497, 2004[CrossRef][Medline] 6. Lilenbaum R: Management of advanced non-small-cell lung cancer in patients with a performance status of 2. Clin Lung Cancer 5:209-513, 2004[Medline]
7. Langer CJ: Dilemmas in management: The controversial role of chemotherapy in PS 2 advanced NSCLC and the potential role of CT-2103 (Xyotax). Oncologist 9:398-405, 2004
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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