Patients with advanced non-small cell lung cancer are often given six courses of chemotherapy, and some patients are continually treated as long as the disease is kept at bay. Now a British study, published in the 01 March 2001, issue of the Journal of Clinical Oncology, indicates that three rounds of treatment may offer the same benefit to patients as six or more.
The report, which involved 308 patients with stage IIIb or IV tumors, is the first to address the optimal duration of chemotherapy for patients with this type of cancer. Despite improvements in cancer treatment, patients with non-small cell lung cancer -- the most common form of lung cancer -- often have a poor prognosis; most die within 12 months of receiving the diagnosis because the disease has already spread outside the lungs.
"Our trial for the first time shows no significant clinical benefit for continuing chemotherapy...beyond three courses in terms of symptom relief, objective response rate, survival, or quality of life," report Ian E. Smith, Royal Marsden National Health Service Trust, and his colleagues from five other United Kingdom centers that participated in the trial.
Patients in the study had no prior chemotherapy for their tumors and were assigned by chance to receive either three or six courses of a drug regimen consisting of mitomycin, vinblastine and cisplastin. The drug regimen was given every 21 days. Those patients receiving fewer rounds of treatment had no better or worse outcomes than those receiving the standard six courses of treatment.
Both groups of patients had relief from symptoms such as cough and shortness of breath for about 4.5 months. And they lived, on average, the same amount of time -- six months for those given three courses of treatment versus seven months for those who received the higher number of treatments. Those given fewer chemotherapy doses also felt significantly less fatigue and tended to have less nausea and vomiting. Overall health, physical functioning, and emotional well being for those given three rounds of treatment were at least as good as for those given six.
"Our findings challenge current orthodoxy on treatment duration" for advanced non-small cell lung cancer, the authors state. But, the researchers caution, only 31 percent of the patients randomized to receive six rounds of treatment actually completed all six courses -- most stopped treatment because their disease progressed. This fallout of participants may have masked the benefit of continued chemotherapy in those who actually did well after the initial three courses.
In addition, the researchers note that newer combinations of medications now available -- such as cisplatin given with vinorelbine, paclitaxel or gemcitabine -- may provide clinical benefit beyond three courses of treatment. However, such possible gain is questionable, the scientists write, given that the new drug combinations have shown only modestly increased response rates and, as yet, no significant advantages in terms of survival.
"Given the current state of therapy for non-small cell lung cancer, continued clinical studies are needed to find better treatments and the optimal duration of those treatments, especially as they relate to improving survival for patients with this disease," said Scott Saxman, senior investigator with NCI's Cancer Therapy Evaluation Program.