ELVIS Study Results Offer Hope to Elderly Lung Cancer Patients

Nearly one-third of the estimated 144,000 patients who are diagnosed with non-small-cell lung cancer (NSCLC) in the United States each year are over the age of 65 years. Elderly patients often do not have access to the range of treatment options available to younger patients. For instance, a study published late last year found that younger patients with advanced NSCLC were three times more likely to receive chemotherapy than were older patients. Besides increased sensitivity to the side effects of platinum-based chemotherapy, elderly patients often have other diseases, as well as diminished physical resilience. Add poor survival prognosis for advanced NSCLC to these factors and the result has been fewer treatment options for elderly lung cancer patients.

Single-Agent Chemotherapy Effective in Elderly

An article in a recent issue of the Journal of the National Cancer Institute offers elderly lung cancer patients a chemotherapy regimen that reduces symptoms and treatment side effects and may prolong life. The Elderly Lung Cancer Vinorelbine Italian Study Group (ELVIS) reports on the first multicenter, randomized clinical trial examining single-agent chemotherapy with vinorelbine (Navelbine) in elderly lung cancer patients.

“We feel the results of this trial show that treatment with vinorelbine may be a valuable option for elderly non-small-cell lung cancer patients. This is the first treatment option we discuss,” said principal researcher, Dr. Cesare Gridelli of the Instituto Nazionali per la Studio e la Cura del Tumori in Naples, Italy. Dr. Gridelli and his colleagues recommend that single-agent vinorelbine become the control arm for future studies exploring chemotherapy in elderly lung cancer patients.

The ELVIS study divided 161 patients over 70 years of age with late-stage NCSLC into two arms. Patients in the chemotherapy arm received vinorelbine, while those in the control arm received supportive care only. Self-directed questionnaires measured quality-of-life factors. Although the study was flawed by low enrollment, results were encouraging enough to cause researchers to begin administering vinorelbine to patients in the control arm before the study’s projected conclusion.

Survival Advantage

Besides finding improved quality of life, researchers discovered a clear survival advantage for patients treated waith the vinorelbine regimen compared to those in the control group. Nearly twice as many patients on the vinorelbine arm were alive 1 year into the study. Vinorelbine-treated patients also had fewer of the symptoms of lung cancer, such as pain and shortness of breath. (Of the 78 patients in the vinorelbine group, 5 were removed from the trial due to either severe constipation or arrhythmia.)

Dr. James Rigas, director of thoracic oncology at the Norris Cotton Cancer Center of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, is encouraged by the ELVIS results. “I am so happy to see this study finally published. I think a lot of physicians were already using vinorelbine for their elderly patients. They knew it was gentler [than mixed-agent chemotherapy] but were unsure if it was really helpful. The ELVIS study shows it increases survival time and maintains good quality of life.”

However, the perception that chemotherapy is exceedingly harsh persists among many elderly patients, said Dr. Rigas. He hopes more physicians will gain confidence about prescribing vinorelbine and realize the value of getting to know each patient as a unique person. “I routinely tell elderly lung cancer patients ‘we can help you live longer, with fewer symptoms.’ Then I find out about their life, what they want to live for, and we decide together what’s right for them.”

Perspectives of Patients Treated With Vinorelbine

One of Dr. Rigas’ patients, 73-year-old June Charron of Lyndonville, Vermont, has been living with lung cancer since 1995. She has had two surgeries and two recurrences. When she learned that cancer had returned to both lungs, she was leery of chemotherapy. After consulting with Dr. Rigas, Ms. Charron began treatment with mitomycin (Mutamycin) and vinorelbine but experienced low white blood cell counts and switched to therapy with vinorelbine alone.

“It’s been over a year now and the cancer hasn’t progressed. I go through chills, then hot flashes the day of treatment, once every 4 weeks, but after that I feel fine,” she said.

Another of Dr. Rigas’ patients, David Moyer, 73 years old, of Hanover, New Hampshire, began vinorelbine treatments last April, after surgery was ruled out for a tumor in his right lung.

“I’m tolerating the Navelbine very well,“ he commented. “But first, I had a sizable conference with Dr. Rigas. He said the side effects vary from individual to individual. After that talk, I wasn’t as apprehensive.”

Mr. Moyer was fatigued during the first few courses of treatment, but now feels well enough to walk over 2 miles a day. He regards chemotherapy as a holding action. “This is not going to cure it but maybe it will hold it in check till they find something that will,” he said.

Advocacy Group Praises Study

Peggy McCarthy, executive director of the Alliance for Lung Cancer Advocacy, Support and Education (ALCASE), praised the ELVIS report as a breakthrough for elderly patients.

“This is a very important study and shows that treatment with single-agent chemotherapy is a valid option for elderly patients. We hope this is only the first of many studies in the treatment of lung cancer in the elderly,” Ms. McCarthy said.

“Based on our telephone calls, we know that a large number of elderly patients are told by their diagnosing physician that there is no medical care available for them. This study should be read by every physician who diagnoses and treats lung cancer so that all elderly patients are aware of their treatment options. Not only does single-agent treatment show an acceptable level of side effects and relief of disease-related symptoms, but it may allow older patients to be alive for those moments that matter to them—a grandchild’s wedding or great-nephew’s graduation.”