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Key Words

Non-small cell lung cancer, elderly, vinorelbine, cisplatin. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Elderly patients with early-stage non-small cell lung cancer who received chemotherapy following surgery lived longer than those who’d had surgery alone, without an increase in treatment-related toxicity or hospitalization. These results provide more evidence that chemotherapy should not be withheld from elderly patients on the basis of age alone.

Source

American Society of Clinical Oncology (ASCO) annual meeting, Atlanta, June 2, 2006. Final results subsequently published in the April 20, 2007, Journal of Clinical Oncology (see the journal abstract).

Background

The majority of patients diagnosed with non-small cell lung cancer are over the age of 65. These elderly patients are likely to have additional health problems, which can cause doctors to question the use of aggressive treatment for their cancer. Few clinical trials of chemotherapy have focused specifically on elderly patients, and the question remains whether the benefits of chemotherapy outweigh the risk of additional side effects in this group.

Between 1994 and 2001, the JBR.10 trial randomly assigned 482 patients with stage IB or II non-small cell lung cancer (NSCLC) to one of two groups. One group had surgery to remove their tumors followed by four rounds of chemotherapy with vinorelbine and cisplatin. The other group were treated with surgery alone, then observed. The results from the trial showed that the surgery plus chemotherapy group lived longer (see Post-Surgery Chemotherapy Improves Survival in Early Lung Cancer).

The original analysis did not address the question of whether survival and side effects were any different between older patients and younger patients.

The Study

In the current study, investigators looked back over the data from the JBR.10 trial and noted that of the 482 participants, 155 were older than 65 and 327 were aged 65 or younger. In the surgery plus chemotherapy group, there were 63 elderly and 150 younger patients. In the surgery alone group, there were 92 elderly and 177 younger patients.

The investigators looked at whether the trial’s overall survival advantage for the surgery plus chemotherapy group held even if the patients were elderly. They also looked at the surgery plus chemotherapy group to see if there were differences between the elderly and younger patients in terms of the number of doses they received, the intensity of the dose, or the side effects.

The JBR.10 trial was a cooperative effort of the North American Intergroup, and was led by the National Cancer Institute of Canada Clinical Trials Group. The lead author of the retrospective study is Carmela Pepe, M.D., of Princess Margaret Hospital, in Toronto, Canada (see the protocol summary).

Results

Sixty-six percent of elderly patients who received chemotherapy were alive five years after treatment, compared with 46 percent in the surgery-alone group – evidence that adding chemotherapy helped regardless of the patients’ age. This survival advantage was seen even though elderly patients received fewer, and less intense, doses than the younger patients in the chemotherapy group. For reasons that weren’t recorded in the original trial, fewer elderly patients completed all four rounds of their treatment.

Elderly patients who received chemotherapy were no more likely to be hospitalized during treatment than were younger patients (28 percent versus 29 percent, respectively). Elderly patients also experienced about the same level of toxic side effects as younger patients.

Limitations

The analysis by age was not part of the original trial design – such retrospective, subset analyses aren’t as strong as prospective trials.

Also, the age-related findings might not be generally true for all elderly. That’s because the participants in the trial may have been in better overall health than other elderly, in order to have qualified to enter the trial.

Finally, the fact that elderly patients in the chemotherapy group suffered no worse side effects than the younger patients could be due to the elderly having received fewer, and less intense, chemotherapy doses.

Comments

Nonetheless, says Janet Dancey, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program, “these findings are as strong as you can get with a retrospective, subset study. The fact that the subset outcome matched the overall outcome is a sign” that the age-related observations are true. Also, she adds, these findings, which concern early-stage lung cancer, are similar to studies in advanced lung cancer in which the elderly benefited from chemotherapy just as much as younger patients, with no more risk of undue side effects.

This study provides an important springboard for future studies, says Pepe, the lead author: “I think the take-home message is that regardless of the intensity or amount of chemotherapy that [elderly participants received], the survival benefit was actually quite striking.”

These retrospective data are “encouraging,” she added, “but what we desperately need is prospective trials…[W]e had very few patients with age greater than 75…so a lot of work needs to be done to try to better understand those groups of patients.”

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