Study Confirms Value of Paclitaxel Plus Paraplatin in NSCLC

According to the results of a landmark phase III, multicenter, Southwest Oncology Group clinical trial (SWOG 9509), the use of paclitaxel (Taxol) plus carboplatin (Paraplatin) can be considered a standard regimen for non–small-cell lung cancer (NSCLC). The study randomized 444 patients with untreated advanced NSCLC at more than 100 US sites to either paclitaxel plus carboplatin or vinorelbine (Navelbine) plus cisplatin. The results of the study were presented at the 35th annual meeting of the American Society of Clinical Oncology (ASCO).

The study also confirmed that paclitaxel plus carboplatin is a safe combination with minimal side effects, offering patients an improved quality of life. The study is significant because it adds to a growing database of scientific research demonstrating that tumors in the lung respond well to paclitaxel plus carboplatin. It is estimated that only 25% of eligible lung cancer patients currently receive chemotherapy, despite data demonstrating that chemotherapy extends survival and enhances quality of life.

Longer Survival, Fewer Adverse Events

In the SWOG 9509 study, paclitaxel plus carboplatin produced a 1-year survival rate of 38%, and vinorelbine plus cisplatin yielded a 1-year survival rate of 36%. These survival rates are clearly superior to the 25% 1-year survival rate associated with older cisplatin-based regimens and the 10% 1-year survival rate seen with best supportive care or no active treatment.

In addition to the 38% 1-year survival rate, paclitaxel plus carboplatin produced statistically significant improvements in other key parameters, including nausea and severe hematologic toxicity. Paclitaxel-carboplatin, however, was associated with higher percentages of grade 3 neuropathy, although these rates were low overall for both arms (8% vs 3%).

“Because Taxol plus Paraplatin therapy is well tolerated, it improves survival and increases quality of life,” said Karen Kelly, MD, of the University of Colorado Cancer Center, lead investigator of the study. “Non–small-cell lung cancer patients now have several treatment options available to them, and this study confirms that Taxol plus Paraplatin should be considered among the standard regimens currently available.”

Paclitaxel plus carboplatin will be the favored regimen in future SWOG studies because of its favorable toxicity profile, better tolerability and compliance, and versatility in combination with radiation therapy and surgery. Other cooperative oncology groups have adopted the paclitaxel-carboplatin combination as the standard arm for current and future trials in NSCLC.

Multimodality Therapy Increases Survival Rates

Several completed and ongoing trials have explored the role of paclitaxel plus carboplatin chemotherapy in combination with surgery and radiation therapy in earlier stages of disease (stage I-III disese).

According to Paul Bunn, Jr,. MD, Grohne-Stapp Professor and director, University of Colorado Cancer Center, “The future of non–small-cell lung cancer treatment lies in multimodality therapies that will offer lung cancer patients the greatest chance for survival, and significantly enhance their quality of life. Taxol has emerged as one of the most active drugs to treat lung cancer. We will continue to study Taxol combinations and its use with surgery and radiation in earlier-stage disease.”

At the ASCO meeting, Katherine Pisters, MD, of the University of Texas M.D. Anderson Cancer Center, presented the significant results of a collaborative effort involving key SWOG institutions, M. D. Anderson, and other comprehensive cancer centers across the nation. This Biomodality Lung Oncology Team (BLOT) study using paclitaxel plus carboplatin in combination with surgery resulted in a high response rate of 54% and allowed surgeons to completely resect tumors in 84% of patients. The study reported an 87% 1-year survival rate for patients with stage I-II NSCLC who were eligible for surgery. It established the safety and feasibility of this combined-modality approach designed to improve both local and systemic control of early-stage NSCLC.

A national randomized trial is currently pending activation and will involve all of the major cooperative groups. This study will compare the BLOT combined-modality regimen to surgery alone.

“We are very encouraged by the promising improvements in survival in the treatment of lung cancer,” said Peggy McCarthy, executive director, Alliance for Lung Cancer Advocacy, Support and Education. “It is critical that lung cancer patients consult with a medical oncologist to understand all of their treatment options.”

According to the results of a landmark phase III, multicenter, Southwest Oncology Group clinical trial (SWOG 9509), the use of paclitaxel (Taxol) plus carboplatin (Paraplatin) can be considered a standard regimen for non–small-cell lung cancer (NSCLC). The study randomized 444 patients with untreated advanced NSCLC at more than 100 US sites to either paclitaxel plus carboplatin or vinorelbine (Navelbine) plus cisplatin. The results of the study were presented at the 35th annual meeting of the American Society of Clinical Oncology (ASCO).

The study also confirmed that paclitaxel plus carboplatin is a safe combination with minimal side effects, offering patients an improved quality of life. The study is significant because it adds to a growing database of scientific research demonstrating that tumors in the lung respond well to paclitaxel plus carboplatin. It is estimated that only 25% of eligible lung cancer patients currently receive chemotherapy, despite data demonstrating that chemotherapy extends survival and enhances quality of life.

Longer Survival, Fewer Adverse Events

In the SWOG 9509 study, paclitaxel plus carboplatin produced a 1-year survival rate of 38%, and vinorelbine plus cisplatin yielded a 1-year survival rate of 36%. These survival rates are clearly superior to the 25% 1-year survival rate associated with older cisplatin-based regimens and the 10% 1-year survival rate seen with best supportive care or no active treatment.

In addition to the 38% 1-year survival rate, paclitaxel plus carboplatin produced statistically significant improvements in other key parameters, including nausea and severe hematologic toxicity. Paclitaxel-carboplatin, however, was associated with higher percentages of grade 3 neuropathy, although these rates were low overall for both arms (8% vs 3%).

“Because Taxol plus Paraplatin therapy is well tolerated, it improves survival and increases quality of life,” said Karen Kelly, MD, of the University of Colorado Cancer Center, lead investigator of the study. “Non–small-cell lung cancer patients now have several treatment options available to them, and this study confirms that Taxol plus Paraplatin should be considered among the standard regimens currently available.”

Paclitaxel plus carboplatin will be the favored regimen in future SWOG studies because of its favorable toxicity profile, better tolerability and compliance, and versatility in combination with radiation therapy and surgery. Other cooperative oncology groups have adopted the paclitaxel-carboplatin combination as the standard arm for current and future trials in NSCLC.

Multimodality Therapy Increases Survival Rates

Several completed and ongoing trials have explored the role of paclitaxel plus carboplatin chemotherapy in combination with surgery and radiation therapy in earlier stages of disease (stage I-III disese).

According to Paul Bunn, Jr,. MD, Grohne-Stapp Professor and director, University of Colorado Cancer Center, “The future of non–small-cell lung cancer treatment lies in multimodality therapies that will offer lung cancer patients the greatest chance for survival, and significantly enhance their quality of life. Taxol has emerged as one of the most active drugs to treat lung cancer. We will continue to study Taxol combinations and its use with surgery and radiation in earlier-stage disease.”

At the ASCO meeting, Katherine Pisters, MD, of the University of Texas M.D. Anderson Cancer Center, presented the significant results of a collaborative effort involving key SWOG institutions, M. D. Anderson, and other comprehensive cancer centers across the nation. This Biomodality Lung Oncology Team (BLOT) study using paclitaxel plus carboplatin in combination with surgery resulted in a high response rate of 54% and allowed surgeons to completely resect tumors in 84% of patients. The study reported an 87% 1-year survival rate for patients with stage I-II NSCLC who were eligible for surgery. It established the safety and feasibility of this combined-modality approach designed to improve both local and systemic control of early-stage NSCLC.

A national randomized trial is currently pending activation and will involve all of the major cooperative groups. This study will compare the BLOT combined-modality regimen to surgery alone.

“We are very encouraged by the promising improvements in survival in the treatment of lung cancer,” said Peggy McCarthy, executive director, Alliance for Lung Cancer Advocacy, Support and Education. “It is critical that lung cancer patients consult with a medical oncologist to understand all of their treatment options.”