REVIEWTaxanes as first-line therapy for advanced non-small cell lung cancer: A systematic review and practice guideline
Introduction
Lung cancer is the leading cause of cancer deaths in men worldwide and the second leading cause of cancer deaths in women, with an estimated 1.1 million deaths globally in 2000 [1]. Non-small cell histology accounts for 70–80% of lung cancer diagnoses [2] and the disease is generally diagnosed at an advanced stage. The long-term survival of patients with advanced non-small cell lung cancer (NSCLC) remains poor, typically less than 5% at 5 years [2], and additional treatment options continue to be explored. The chemotherapy agents, paclitaxel (Taxol®) and docetaxel (Taxotere®) are the first two cytotoxics of the taxane family. Taxanes bind preferentially to microtubules leading to stabilization, which are involved in the formation of mitotic spindles during M phase of the cell cycle. Given the promising results of these two agents with advanced NSCLC in phase II trials [3], [4], the Lung Cancer Disease Site Group (Lung DSG) of Cancer Care Ontario's Program in Evidence-based Care decided to develop an evidence-based clinical practice guideline to address the question: is there a role for taxanes (paclitaxel or docetaxel), alone or in combination with other chemotherapy agents, in the first-line treatment of advanced NSCLC?
This guideline, while complete, has been edited and condensed for publication. The unabridged version, along with other practice guidelines developed through the Program, is available on the Cancer Care Ontario website at http://www.cancercare.on.ca/. Care has been taken in the preparation of the information contained in this document. Nonetheless, any clinician seeking to apply or consult the practice guideline is expected to use independent medical judgment in the context of individual clinical circumstances.
Section snippets
Methods
This practice guideline was developed by the multidisciplinary Lung DSG, which includes medical and radiation oncologists, thoracic surgeons, nurses, a medical sociologist, patient representatives, and research coordinators, using the Practice Guidelines Development Cycle [5]. The guideline is based on a systematic review of evidence and is intended to promote evidence-based practice and improve outcomes for cancer patients.
Literature search results
One relevant evidence-based practice guideline was identified and reviewed prior to making the decision to develop the current practice guideline [6], and two practice guidelines were published during the development of the current guideline [7], [8]. Forty-five studies, 29 involving paclitaxel [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], and 18 involving
Discussion
Both single agent paclitaxel and docetaxel are active in advanced NSCLC, achieving a significant improvement in overall survival compared with BSC, with an acceptable incidence of grade 3 or 4 toxicity [9], [40]. A modest QOL benefit has also been detected with docetaxel [40]. However, it is unclear if a single agent taxane would improve survival compared with another single agent chemotherapy because there are limited data on such comparisons [10], [41]. In addition, no published trials have
External review of the guideline
Feedback on a draft version of this guideline was solicited through a mailed survey of 106 Ontario practitioners in September 2003. The draft guideline summarized data from 29 randomized trials and the primary recommendations were consistent with those of the current guideline. Of the 51 respondents, 27 indicated that the report was relevant to their clinical practice and provided feedback on the draft report: 89% agreed with the draft recommendations and 81% indicated they would be likely to
Practice guideline
Based on the evidence reviewed, the Lung DSG developed the following recommendations for the treatment of adult patients with advanced NSCLC who are considered candidates for palliative, first-line chemotherapy:
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The combination of paclitaxel or docetaxel with cisplatin can be recommended as one of a number of chemotherapy options in the first-line therapy of patients with advanced NSCLC and a good performance status.
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In patients who have a contraindication to the use of cisplatin or who
Acknowledgements
The Program in Evidence-based Care is sponsored by, but editorially independent of, Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care. The authors of this review and guideline disclosed the following potential conflicts of interest with the companies that developed docetaxel (Aventis) or paclitaxel (Bristol-Myers Squibb): consultancy with Aventis (Dr. Vincent), participation in Aventis sponsored research or advisory Boards (Drs. Vincent and Evans), or receipt of
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Yasmin Alam, Grace Bradish, Michael Brundage, Susanna Cheng, A.R. Dar, Gail Darling, Catherine de Metz, Brian Dingle, Peter Dixon, Peter Ellis, Conrad Falkson, Ronald Feld, Glen Goss, Ian Graham, Richard Gregg, Adam Haynes, Cathy Kiteley, Walter Kocha, Jaro Kotalik, Scott Laurie, Robert MacRae, Richard Malthaner, Donna Maziak, Joanne Meng, John Miller, Jonathan Noble, Gordon Okawara, Frances Shepherd, David Stewart, Yee Chung Ung, David Walde, Edward Yu, and two patient representatives also contributed to the development of this review and practice guideline. Please see the Cancer Care Ontario Web site for a complete list of current Lung Cancer Disease Site Group members (http://www.cancercare.on.ca/).