Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial
The Lancet Oncology,  Clinical Article

Zhang L et al. – Maintenance treatment with gefitinib significantly prolonged progression-free survival compared with placebo in patients from east Asia with advanced NSCLC who achieved disease control after first-line chemotherapy.

Methods

  • Patients were aged 18 years or older, were of east Asian ethnic origin, had a life expectancy of more than 12 weeks, histologically or cytologically confirmed stage IIIb or IV NSCLC, a WHO performance status of 0—2, and had completed four cycles of first-line platinum-based doublet chemotherapy without disease progression or unacceptable toxic effects.
  • Between Sept 28, 2008 and Aug 11, 2009, 296 patients were randomly assigned 1:1 to receive either gefitinib (250 mg per day orally) or placebo (orally) within 3—6 weeks after chemotherapy until progression or unacceptable toxic effects.
  • Randomisation was done via an interactive web response system with computer-generated randomisation codes.
  • Our primary endpoint was progression-free survival assessed in the intention-to-treat population.

Results
  • Progression-free survival was significantly longer with gefitinib (n=148) than with placebo (148) (median progression-free survival 4·8 months [95% CI 3·2—8·5] vs 2·6 months [1·6—2·8]; hazard ratio [HR] 0·42, 95% CI 0·33—0·55; p<0·0001).
  • Adverse events occurred more frequently with gefitinib than with placebo; the most common adverse events of any grade were rash (73 [50%] of 147 in the gefitinib group vs 14 [9%] of 148 in the placebo group), diarrhoea (37 [25%] vs 13 [9%]), and alanine aminotransferase increase (31 [21%] vs 12 [8%]).
  • The most commonly reported grade 3 or 4 adverse event was alanine aminotransferase increase (3 [2%] of 147 in the gefitinib group, none of 148 in the placebo group).
  • Ten of 147 (7%) patients given gefitinib and five of 148 (3%) patients given placebo had serious adverse events.
  • Three deaths were thought to be related to treatment with gefitinib: one from interstitial lung disease; one from lung infection; and one from pneumonia.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Oncology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Oncology Articles

1 Long-term results of a randomised phase III trial of weekly versus three-weekly paclitaxel/platinum induction therapy followed by standard or extended three-weekly paclitaxel/platinum in European patients with advanced epithelial ovarian cancer European Journal of Cancer, August 6, 2014    Clinical Article

2 Optimal duration of low molecular weight heparin for the treatment of cancer-related deep vein thrombosis: The Cancer-DACUS Study Journal of Clinical Oncology, October 10, 2014    Clinical Article

3 Metformin in chemotherapy-naive castration-resistant prostate cancer: A multicenter phase 2 trial (SAKK 08/09) Full Text European Urology, August 15, 2014    Free full text    Clinical Article

4 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 23, 2014    Clinical Article

5 Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial The Lancet Oncology, October 3, 2014    Clinical Article

6 Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): A randomised, open-label, phase 3 trial The Lancet Oncology, October 7, 2014    Clinical Article

7 Pathologic findings at risk-reducing salpingo-oophorectomy: Primary Results From Gynecologic Oncology Group Trial GOG-0199 Journal of Clinical Oncology, September 22, 2014    Clinical Article

8 Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial The Lancet Oncology, October 20, 2014    Clinical Article

9 Elevated platelet to lymphocyte ratio predicts poor prognosis after hepatectomy for liver-only colorectal metastases, and it is superior to neutrophil to lymphocyte ratio as an adverse prognostic factor Medical Oncology, September 22, 2014    Clinical Article

10 Annexin-A2 as predictor biomarker of recurrent disease in endometrial cancer International Journal of Cancer, September 29, 2014    Clinical Article

11 Six versus fewer planned cycles of first-line platinum-based chemotherapy for non-small-cell lung cancer: A systematic review and meta-analysis of individual patient data The Lancet Oncology, September 24, 2014    Clinical Article

12 Lung cancer probability in patients with CT-detected pulmonary nodules: A prespecified analysis of data from the NELSON trial of low-dose CT screening The Lancet Oncology, October 9, 2014    Clinical Article

13 Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): A double-blind, randomised phase 3 trial The Lancet Oncology, September 25, 2014    Clinical Article

14 Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): An open-label, randomised phase 3 trial The Lancet Oncology, October 8, 2014    Clinical Article

15 Salt tea consumption and esophageal cancer, a possible role of alkaline beverages in esophageal carcinogenesis International Journal of Cancer, September 15, 2014    Clinical Article

16 Everolimus plus exemestane for hormone-receptor–positive, human epidermal growth factor receptor-2–negative advanced breast cancer: Overall survival results from BOLERO-2 Annals of Oncology, September 30, 2014    Clinical Article

17 Effect of radiotherapy after breast-conserving surgery for ductal carcinoma in situ: 20 years follow-up in the Randomized SweDCIS Trial Journal of Clinical Oncology, October 17, 2014    Clinical Article

18 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 30, 2014    Clinical Article

19 Screening for prostate cancer in the US? Reduce the harms and keep the benefit International Journal of Cancer, August 15, 2014    Clinical Article

20 Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): A randomised, double-blind, phase 3 trial The Lancet Oncology, October 22, 2014    Clinical Article

Indexed Journals in Oncology: Journal of Clinical Oncology, Cancer Research, Annals Oncologymore