Stage IV Non-Small Cell Lung Cancer
Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)
Stage IV non-small cell lung cancer (NSCLC) is defined by the following clinical stage grouping:
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- Any T, any N, M1
Forty percent of patients with newly diagnosed NSCLC have stage IV disease. Randomized controlled trials of patients with stage IV disease and stage IIIB disease with malignant pleural effusions and good performance status (PS) have shown that cisplatin-based chemotherapy improves survival and palliates disease-related symptoms.[1][Level of evidence: 1iiA] Patients with nonsquamous-cell histology, good PS, no history of hemoptysis or other bleeding or recent history of cardiovascular events may benefit from the addition of bevacizumab to paclitaxel-carboplatin. The role of chemotherapy in patients with poor PS was less certain. Second-line chemotherapy with docetaxel, pemetrexed, or erlotinib also improves survival patients with good PS.[1][Level of evidence: 1iiA]
Several randomized trials have evaluated various drugs combined with either cisplatin or carboplatinum in previously untreated patients with advanced NSCLC. Based on meta-analyses of the trials the following conclusions can be drawn:
- Certain three-drug combinations that add so-called targeted agents may result in superior survival.
- Epidermal growth factor receptor (EGFR) inhibitors may benefit selected patients with EGFR mutations.
- Maintenance chemotherapy following four cycles of platinum combination chemotherapy may improve progression-free survival (PFS).
- Platinum combinations with vinorelbine, paclitaxel, docetaxel, gemcitabine, irinotecan, and pemetrexed yield similar improvements in survival. Types and frequencies of toxic effects differ, and these may determine the preferred regimen for an individual patient.
- Cisplatin and carboplatinum yield similar improvements in outcome with different toxicities. Some, but not all, trials and meta-analyses of trials suggest that outcomes with cisplatin may be superior, although with a higher risk of certain toxicities, such as nausea and vomiting.
- Nonplatinum combinations offer no advantage to platinum-based chemotherapy, and some studies demonstrate inferiority.
- Three-drug combinations of the commonly used chemotherapy drugs do not result in superior survival and are more toxic than two-drug combinations.
Chemotherapy in Combination with Bevacizumab or Cetuximab
Two randomized trials have evaluated the addition of bevacizumab, an antibody targeting vascular endothelial growth factor to standard first-line combination chemotherapy. In a randomized study of 878 patients with recurrent or advanced stage IIIB or stage IV NSCLC, 444 received paclitaxel and carboplatin alone, and 434 patients received paclitaxel and carboplatin plus bevacizumab.[2] Chemotherapy was administered every 3 weeks for six cycles, and bevacizumab was administered every 3 weeks until disease progression was evident or toxic effects were intolerable. Patients with squamous cell tumors, brain metastases, clinically significant hemoptysis, or inadequate organ function or PS (Eastern Cooperative Oncology Group PS >1) were excluded. The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapy-alone group (hazard ratio [HR] for death = 0.79; P = .003). The median PFS in the two groups was 6.2 months and 4.5 months, respectively (HR for disease progression, 0.66; P < .001), with corresponding response rates of 35% and 15% (P < .001). Rates of clinically significant bleeding were 4.4% and 0.7%, respectively (P < .001). There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group, including five from pulmonary hemorrhage. For this subgroup of patients with NSCLC, the addition of bevacizumab to paclitaxel and carboplatin may provide survival benefit.[2][Level of evidence: 1iiA]
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