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There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
What lesson can we learn from this study, and how should the results influence current management of elderly patients with lung cancer?
It is important to accurately interpret the finding of this study, which is that the combination of cisplatin/docetaxel administered on a weekly schedule is not superior to single-agent docetaxel given every 3 weeks in patients older than 70 years of age with lung cancer. The study does not negate the well-founded recognition that patient age does not preclude clinical benefit of systemic anticancer therapy and that elderly patients with lung cancer should be offered systemic therapy if they are fit enough to tolerate the treatment.
Although the study was designed to evaluate treatment efficacy in elderly patients, only patients who were unsuitable for bolus cisplatin infusion were included. As there is no clear definition for patients unsuitable for bolus cisplatin, we believe that this might have led to the enrollment of a patient subset with unfavorable prognosis. The interpretation, external validity, and generalizability of the result of this study are greatly limited because the unwieldy definition of patients considered unsuitable for cisplatin makes it difficult to establish how well the study population represents the elderly patient population with lung cancer.
There is increasing agreement that treatment decisions for elderly patients should be based on performance status, comorbid conditions, and patient preferences. Treatment decisions based entirely on chronological age and not informed by the tremendous knowledge gained in optimal assessment of older patients in recent years do not serve our patients well. Finally, it is imperative to include functional assessment as an integral component of clinical trials designed for older patients.
Dr. Taofeek K. Owonikoko and Dr. Suresh S. Ramalingam are with Emory University and Winship Cancer Institute, Atlanta. These remarks were extracted from the accompanying editorial (J. Clin. Onc. 2015 Jan. 12 [doi:10.1200/JCO.2014.59.5033]).
There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
On Twitter @nikolaideslaura
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced non–small cell lung cancer.
Major finding: Overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49).
Data source: Randomized phase III Japanese trial of 276 elderly patients with stage III, stage IV, or recurrent non–small cell lung cancer (Intergroup Trial JCOG0803/WJOG4307L).
Disclosures: Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
