Taxanes as first-line therapy for advanced non-small cell lung cancer: A systematic review and practice guideline

doi:10.1016/j.lungcan.2005.06.010

Lung Cancer

Volume 50, Issue 3, December 2005, Pages 355-374

https://doi.org/10.1016/j.lungcan.2005.06.010 Get rights and content

Summary

This evidence-based practice guideline on the use of paclitaxel (Taxol^®) or docetaxel (Taxotere^®) as first-line treatment for patients with advanced non-small cell lung cancer who are candidates for palliative first-line chemotherapy is based on a systematic search and review of literature published in full or in abstract form between 1985 and April 2005. Forty-five randomized trials, including 11 abstracts, were reviewed and clinicians in the province of Ontario, Canada, provided feedback on a draft version of the guideline. Two phase III trials detected a statistically significant survival advantage for a taxane (paclitaxel or docetaxel) with best supportive care versus best supportive care alone. Among the nine fully published phase III trials comparing platinum-based chemotherapies, taxane-platinum combinations achieved higher response rates compared with older chemotherapy combinations, although significantly longer survival was observed only for docetaxel-cisplatin compared with vindesine-cisplatin. Response rates and survival were generally not significantly different for taxane-platinum combinations compared with other current chemotherapy combinations, although the toxicity profile of the regimens varied. However, in one large trial, improved tumor response and modest survival and quality of life benefits were associated with docetaxel-cisplatin compared with vinorelbine-cisplatin. No statistically significant survival differences were detected in the three fully published phase III trials comparing a taxane-gemcitabine combination with a taxane-platinum regimen.

Recommendations: (i) paclitaxel or docetaxel combined with cisplatin is recommended as one of a number of chemotherapy options for the first-line treatment of advanced non-small cell lung cancer in patients with a good performance status; (ii) carboplatin may be combined with a taxane if a patient is unable or unwilling to take cisplatin; (iii) a taxane-gemcitabine combination may be considered for patients with a contraindication to cisplatin and carboplatin; (iv) no firm recommendation can be made on the optimal dose and schedule of taxane-based chemotherapy; however, commonly used regimens include cisplatin 75 mg/m² combined with either docetaxel 75 mg/m² or paclitaxel 135 mg/m² (24-h infusion) and carboplatin AUC 6 combined with paclitaxel 225 mg/m² (3-h infusion); (v) a single-agent taxane may be used if combination chemotherapy is considered inappropriate.

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:

•
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.
•
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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¹: 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/).

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REVIEWTaxanes as first-line therapy for advanced non-small cell lung cancer: A systematic review and practice guideline

Summary

Introduction

Section snippets

Methods

Literature search results

Discussion

External review of the guideline

Practice guideline

Acknowledgements

Lancet Oncol

Lancet

Chest

Ann Oncol

Ann Oncol

Ann Oncol

Ann Oncol

Lung Cancer

Semin Oncol

Ann Oncol

Lung Cancer

Eur J Cancer Suppl

Ann Oncol

Lancet

Ann Oncol

Ann Oncol

Ann Oncol

Lancet

Lung cancer

Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

J Clin Oncol

The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation

J Clin Oncol

American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003

J Clin Oncol

Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer

J Natl Cancer Inst

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

Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B (study 9730)

J Clin Oncol

Randomized phase III trial comparing cisplatin/etoposide versus carboplatin/paclitaxel in advanced and metastatic non-small cell lung cancer (NSCLC)

Proc Am Soc Clin Oncol

Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer. The European organization for research and treatment of cancer lung cancer cooperative group

J Clin Oncol

Taxol and cisplatin (TP) versus etoposide cisplatin (EP) in advanced non-small cell lung cancer (NSCLC)

Eur J Cancer

Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an eastern cooperative oncology group trial

J Clin Oncol

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J Clin Oncol

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Taxanes as first-line therapy for advanced non-small cell lung cancer: A systematic review and practice guideline