Erlotinib Improved QOL in Advanced NSCLC, National Cancer Institute of Canada Trial BR.21 Finds

September 1, 2005

This supplement to Oncology News International includes more than 15 reportson presentations made at the 41st annual meeting of the American Society of Clinical Oncology.Reviews focus on the use of targeted agents in non–small-cell lung cancer and other solid tumors,evaluating the novel therapies bevacizumab, cetuximab, bortezomib, erlotinib, and gefitinib, aloneand/or in combination with other chemotherapy agents. Continuing medical education credit isavailable by completing a post-test and evaluation online at www.cancernetwork.com/cme.

TORONTO, Canada-Erlotinib(Tarceva) not only extended survivalin patients with advanced non-smallcelllung cancer (NSCLC) but it alsoimproved their quality of life (QOL),according to data from BR.21, a double-blind randomized placebo-controlledtrial in 731 patients. Pain, cough,and dyspnea got worse at a slower rateamong patients who took erlotinibthan among those who took placeboon the trial, which was conducted bythe National Cancer Institute of Canada(NCIC).The primary findings of BR.21, reportedlast year, showed that erlotinibsignificantly improved median overallsurvival time and 1-year survival, comparedwith placebo, in patients withpreviously treated stage IIIb or IVNSCLC. The QOL data from BR.21were reported by Andrea Bezjak, MD,who led the QOL analysis (abstract7018). Dr. Bezjak is associate professorin the departments of radiation oncologyand health policy, managementand evaluation at the University ofToronto, and is a staff radiation oncologistat Princess Margaret Hospital,Toronto."Patients on erlotinib had slowerdeterioration of their disease-relatedsymptoms and quality of life improvedin more patients on the erlotinib armthan on the placebo arm," Dr. Bezjaksaid. "These differences were clinicallyas well as statistically significant."To collect the data, Dr. Bezjak andher colleagues used the QOL core questionnaireand lung cancer module ofthe European Organization for Researchand Treatment of Cancer(EORTC); the questionnaire was administeredmonthly. Compliance wasexcellent, Dr. Bezjak noted, with 85%of patients completing questionnairesin the first year.

The results showed that the mediantime to deterioration of cough was4.9 months for patients on the erlo-tinib arm of the study vs 3.7 monthsfor those on the placebo arm. For dyspnea,the median time to deteriorationwas 4.7 months vs 2.9 months;and for pain, it was 2.8 months vs 1.9months, respectively.The researchers also analyzed globalQOL by determining how manypatients had an improvement of atleast 10 points during the study. Theyfound that 35% of the patients onerlotinib fell into this category vs 26%of those on placebo. The favorableimpact of erlotinib included less fatigue,which is usually difficult toachieve, Dr. Bezjak noted.Erlotinib is one of several agentsthat have been tested as second-linetherapy in "this burgeoning population"of patients with advancedNSCLC, said discussant Vincent Miller,MD, associate attending physicianin the Thoracic Oncology Service atMemorial Sloan-Kettering CancerCenter, New York. Dr. Miller reviewedtrials with docetaxel (Taxotere), topotecan(Hycamtin), pemetrexed (Alimta),and erlotinib. He concludedthat docetaxel, pemetrexed, and erlotinibare all reasonable choices as second-line therapy but further study isneeded, including trials of combinationtherapies. In addition, he said,"erlotinib, though having a favorablequality-of-life profile, has not yet beencompared with a cytotoxic agent inthis population, and I do think thatwould be a very appropriate study toundertake."