This trial compared combination chemotherapy
and a single-agent combination regimen in 584 patients. The
combination of carboplatin and paclitaxel significantly improved
survival versus paclitaxel as a single agent. Toxicities were
greater in the combination arm, but manageable. Quality of life
was similar between the two regimens. The findings support the
suggestion that combination chemotherapy should be the standard
of care for advanced non-small cell lung cancer.
Lung cancer claims more deaths than breast, prostate and
colon cancer combined. Most patients have advanced disease
at presentation. The 5-year survival rate for advanced lung
cancer is 15%.
Chemotherapy prolongs survival in patients presenting with
advanced disease and good performance status. However, many
physicians and patients are convinced that chemotherapy is
highly toxic and has a negative effect on quality of life.
The Cancer and Leukemia Group B (CALGB) designed a trial
to answer definitively the question of whether combination
chemotherapy improves survival in advanced lung cancer. This
trial compared aggressive chemotherapy with paclitaxel plus
carboplatin to paclitaxel alone in patients with advanced
disease.
Although the primary efficacy endpoint of this study was
survival, investigators also evaluated quality of life. Dr.
Lilenbaum explained that it is helpful to consider quality
of life when choosing between strategies that seem to have
comparable efficacy. In addition, the cost effectiveness of
each regimen was studied.
The trial demonstrated that in fact, the more aggressive
regimen prolonged survival compared with single agent regimen.
With a median follow-up of 12.5 months, median survival
was 8.8 months for paclitaxel-carboplatin and 6.7 months for
paclitaxel (P = 0.013). Even elderly patients had a survival
benefit. Survival rates at 1 year were 37% and 33%, respectively,
but this difference did not achieve statistical significance.
Combination chemotherapy versus
single agent:
Efficacy and safety data
Response
rate | 30% | 16% | <
0.0001 | Median
survival | 8.8
months | 6.7
months | 0.013 | 1-year
survival rate | 37% | 33% | NS | Any
grade 3-4 toxicity | 90% | 73% | <
0.0001 |
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Toxicity was greatest in the combination chemotherapy group.
Of patients on paclitaxel-carboplatin, 89% experienced at
least one grade 3-4 toxicity, compared with 71% for paclitaxel.
However, the increased toxicity was manageable .
Quality of life was similar between the combination chemotherapy
and single agent therapy.
Utilization of health care resources such as antibiotics,
transfusions, hospital admissions or visits to the emergency
room can be used as a surrogate for cost effectiveness. Patients
who received combination chemotherapy did not utilize more
health care resources than those who received single agent
treatment.
Based on this data, investigators believe combination chemotherapy
should be the standard of care for patients with advanced
non-small cell lung cancer and good performance status. Elderly
patients with good performance status should also be considered
for treatment.
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