New ASCO Guidelines for Management of Unresectable NSCLC
New ASCO Guidelines for Management of Unresectable NSCLC
Jan. 23, 2004 — The American Society of Clinical Oncology (ASCO) has updated their guidelines for the treatment of unresectable non-small cell lung carcinoma (NSCLC) and published them in the Jan. 15 issue of the Journal of Clinical Oncology. The new recommendations cover the role of positron emission tomography (PET) scans, selection of first-line and second-line therapies, duration of therapy, and use of helical computed tomography (CT). However, the authors comment that the guidelines are voluntary and do not apply in the context of clinical trials.
"By reviewing and synthesizing the latest literature, this practice guideline serves to identify questions for further research and the settings in which investigational therapy should be considered," write David G. Pfister and colleagues from ASCO in Alexandria, Virginia. "These guidelines describe evaluations and administration of therapies in clinical practice; they cannot be assumed to apply to interventions performed in the context of clinical trials, given that such clinical studies are designed to test innovative management strategies in a disease for which better treatment is sorely needed."
The 2003 guidelines reinforce the 1997 recommendation for chest x-ray and chest CT with contrast to stage locoregional disease, while adding that FDG-PET scanning should be done if there is no evidence of distant metastatic disease on CT scan. For patients with clinically operable NSCLC, mediastinal lymph nodes greater than 1.0 cm on CT or positive on FDG-PET should be biopsied.
Similarly, the new guidelines emphasize the role of FDG-PET in staging distant metastatic disease. The finding of an isolated adrenal or liver mass on ultrasonography, CT, or FDG-PET requires biopsy to rule out metastatic disease in patients who are otherwise considered to be surgical candidates.
Compared with the 1997 guidelines, the 2003 guidelines for treatment recommend no changes regarding outcome, patient selection, timing, role of investigational agents, or histology for patients with unresectable stage III or stage IV NSCLC.
The selection of drugs now differs for stage IV NSCLC in that first-line chemotherapy given to patients with advanced NSCLC should be a two-drug combination regimen. Non–platinum-containing chemotherapy regimens may be used as alternatives to platinum-based regimens in the first line. For elderly patients or patients with ECOG/Zubrod performance status 2, single-agent chemotherapy is acceptable.
Changes in recommended duration of chemotherapy are that in patients with unresectable stage III NSCLC who are candidates for combined chemotherapy and radiation, there should be two to four cycles, and no more than four cycles, of initial platinum-based chemotherapy. First-line chemotherapy should be stopped after four cycles in patients with stage IV NSCLC who are not responding to treatment, and it should not exceed six cycles.
In patients with locally advanced or metastatic NSCLC with adequate performance status who have progressed on first-line platinum-based therapy, docetaxel is now recommended as second-line treatment. After failure of both platinum-based and docetaxel chemotherapies in these patients, gefitinib is now recommended.
There have been no changes in radiotherapy recommendations since 1997. Radiation therapy should be included in the treatment regimen for selected patients with unresectable locally advanced NSCLC.
With respect to surgery, the 2003 guidelines recommend resection followed by whole brain radiation therapy in patients with controlled disease outside of the brain who have an isolated cerebral metastasis in a resectable area. The evidence is insufficient to support routine resection of solitary adrenal metastases, but this is feasible in selected patients.
In asymptomatic patients and in those not awaiting further intervention, the 2003 recommendations are unchanged in terms of monitoring with history and physical examination. There is no clear role for routine chest x-ray; CT of the chest/abdomen; CT /MRI of the brain; FDG-PET; bone scan; bronchoscopy; CBC; and routine chemistries, including liver function tests.
"Low-dose helical chest CT is more sensitive than chest x-ray for the identification of second primary cancers, but at this time remains investigational as part of the routine follow-up of patients with a history of unresectable NSCLC," the authors write.
Recommended lifestyle changes include smoking cessation, never beginning smoking, and avoiding occupational and environmental exposure to carcinogenic substances to reduce the risk of second primary NSCLC. As in 1997, the panel concluded that the use of antioxidants and/or chemopreventive agents for NSCLC is investigational, and their clinical use off-study is not recommended.
"ASCO considers adherence to these guidelines to be voluntary," the authors write. "The ultimate determination regarding their application is to be made by the physician in light of each patient's individual circumstances."
One of the authors has acted as a consultant for Aventis and AstraZeneca within the last two years. The other authors report no financial conflicts of interest.
J Clin Oncol. 2004;22:330-353
Reviewed by Gary D. Vogin, MD
Jan. 23, 2004 — The American Society of Clinical Oncology (ASCO) has updated their guidelines for the treatment of unresectable non-small cell lung carcinoma (NSCLC) and published them in the Jan. 15 issue of the Journal of Clinical Oncology. The new recommendations cover the role of positron emission tomography (PET) scans, selection of first-line and second-line therapies, duration of therapy, and use of helical computed tomography (CT). However, the authors comment that the guidelines are voluntary and do not apply in the context of clinical trials.
"By reviewing and synthesizing the latest literature, this practice guideline serves to identify questions for further research and the settings in which investigational therapy should be considered," write David G. Pfister and colleagues from ASCO in Alexandria, Virginia. "These guidelines describe evaluations and administration of therapies in clinical practice; they cannot be assumed to apply to interventions performed in the context of clinical trials, given that such clinical studies are designed to test innovative management strategies in a disease for which better treatment is sorely needed."
The 2003 guidelines reinforce the 1997 recommendation for chest x-ray and chest CT with contrast to stage locoregional disease, while adding that FDG-PET scanning should be done if there is no evidence of distant metastatic disease on CT scan. For patients with clinically operable NSCLC, mediastinal lymph nodes greater than 1.0 cm on CT or positive on FDG-PET should be biopsied.
Similarly, the new guidelines emphasize the role of FDG-PET in staging distant metastatic disease. The finding of an isolated adrenal or liver mass on ultrasonography, CT, or FDG-PET requires biopsy to rule out metastatic disease in patients who are otherwise considered to be surgical candidates.
Compared with the 1997 guidelines, the 2003 guidelines for treatment recommend no changes regarding outcome, patient selection, timing, role of investigational agents, or histology for patients with unresectable stage III or stage IV NSCLC.
The selection of drugs now differs for stage IV NSCLC in that first-line chemotherapy given to patients with advanced NSCLC should be a two-drug combination regimen. Non–platinum-containing chemotherapy regimens may be used as alternatives to platinum-based regimens in the first line. For elderly patients or patients with ECOG/Zubrod performance status 2, single-agent chemotherapy is acceptable.
Changes in recommended duration of chemotherapy are that in patients with unresectable stage III NSCLC who are candidates for combined chemotherapy and radiation, there should be two to four cycles, and no more than four cycles, of initial platinum-based chemotherapy. First-line chemotherapy should be stopped after four cycles in patients with stage IV NSCLC who are not responding to treatment, and it should not exceed six cycles.
In patients with locally advanced or metastatic NSCLC with adequate performance status who have progressed on first-line platinum-based therapy, docetaxel is now recommended as second-line treatment. After failure of both platinum-based and docetaxel chemotherapies in these patients, gefitinib is now recommended.
There have been no changes in radiotherapy recommendations since 1997. Radiation therapy should be included in the treatment regimen for selected patients with unresectable locally advanced NSCLC.
With respect to surgery, the 2003 guidelines recommend resection followed by whole brain radiation therapy in patients with controlled disease outside of the brain who have an isolated cerebral metastasis in a resectable area. The evidence is insufficient to support routine resection of solitary adrenal metastases, but this is feasible in selected patients.
In asymptomatic patients and in those not awaiting further intervention, the 2003 recommendations are unchanged in terms of monitoring with history and physical examination. There is no clear role for routine chest x-ray; CT of the chest/abdomen; CT /MRI of the brain; FDG-PET; bone scan; bronchoscopy; CBC; and routine chemistries, including liver function tests.
"Low-dose helical chest CT is more sensitive than chest x-ray for the identification of second primary cancers, but at this time remains investigational as part of the routine follow-up of patients with a history of unresectable NSCLC," the authors write.
Recommended lifestyle changes include smoking cessation, never beginning smoking, and avoiding occupational and environmental exposure to carcinogenic substances to reduce the risk of second primary NSCLC. As in 1997, the panel concluded that the use of antioxidants and/or chemopreventive agents for NSCLC is investigational, and their clinical use off-study is not recommended.
"ASCO considers adherence to these guidelines to be voluntary," the authors write. "The ultimate determination regarding their application is to be made by the physician in light of each patient's individual circumstances."
One of the authors has acted as a consultant for Aventis and AstraZeneca within the last two years. The other authors report no financial conflicts of interest.
J Clin Oncol. 2004;22:330-353
Reviewed by Gary D. Vogin, MD
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