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Week of December 26, 2010

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"Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma," by T.S. Mok and 18 others, New England Journal of Medicine, 361(10): 947-57, 3 September 2009.


[Authors' affiliations: 14 Asian and U.K. institutions]

Abstract: "Background: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer.

Methods: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival.

Results: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group.

Conclusions: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib."

This 2009 report from the New England Journal of Medicine was cited 51 times in current journal articles indexed by Thomson Reuters during July-August 2010. During that two-month period, this was the third-most-cited medicine paper published in the last two years, not counting reviews. Prior to the most recent bimonthly count, citations to the paper have accrued as follows:

May-June 2010: 50 citations
March-April 2010: 22
January-February 2010: 31
November-December 2009: 14
September-October 2009: 1

Total citations to date: 169


SOURCE: Hot Papers Database (Included with a subscription to the print newsletter Science Watch®, available from the Research Services Group of Thomson Reuters. Packaged on a CD that is mailed with each Science Watch issue, the Hot Papers Database contains data on hundreds of highly cited papers published during the last two years. User interface permits searching by author, organization, journal, field, and more. Total citations, as well as citations accrued during successive bimonthly periods, can be assessed and graphed. An updated CD containing the most recent bimonthly data is mailed with every new issue of Science Watch, six times a year. The CD also includes an electronic version of the Science Watch issue in HTML format, for personal desktop access.

 
 

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