N Engl J Med. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. Comment in N Engl J Med. BACKGROUND: We conducted a randomized study to determine whether any of three chemotherapy regimens was superior to cisplatin and paclitaxel in patients with advanced non-small-cell lung cancer. METHODS: A total of patients with advanced non-small-cell lung cancer were randomly assigned to a reference regimen of cisplatin and paclitaxel or to one of three experimental regimens: cisplatin and gemcitabine, cisplatin and docetaxel, or carboplatin and paclitaxel. The response rate and survival did not differ significantly between patients assigned to receive cisplatin and paclitaxel and those assigned to receive any of the three experimental regimens.
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MethodsA total of patients with advancednon—small-cell lung cancer were randomly assignedto a reference regimen of cisplatin and paclitaxel orto one of three experimental regimens: cisplatin andgemcitabine, cisplatin and docetaxel, or carboplatinand paclitaxel.
ResultsThe response rate for all eligible pa-tients was 19 percent, with a median survival of 7. The response rate and survival didnot differ significantly between patients assigned toreceive cisplatin and paclitaxel and those assigned toreceive any of the three experimental regimens.
Treat-ment with cisplatin and gemcitabine was associatedwith a significantly longer time to the progression ofdisease than was treatment with cisplatin and pacli-taxel but was more likely to cause grade 3, 4, or 5 re-nal toxicity in 9 percent of patients, vs. Patientswith a performance status of 2 had a significantlylower rate of survival than did those with a perform-ance status of 0 or 1.
ConclusionsNone of four chemotherapy regimensoffered a significant advantage over the others in thetreatment of advanced non—small-cell lung cancer. N Engl J Med ; BackgroundWe conducted a randomized study to as compared with supportive care, chemotherapy re-sults in a small improvement in survival in patientswith advanced non—small-cell lung cancer.
The combination of oneor more of these agents with a platinum compoundhas resulted in high response rates and prolongedsurvival at one year in phase 2 studies. The Eastern Cooperative Oncology Group ECOG conducted a randomized clinical trial tocompare the efficacy of three commonly used regi-mens with that of a reference regimen of cisplatinand paclitaxel.
The first group received the reference treat-ment: mg of paclitaxel per square meter of body-surface area,administered over a hour period on day 1, followed by 75 mgof cisplatin per square meter on day 2. The cycle was repeated ev-ery three weeks. In the second group, gemcitabine, at a dose of mg per square meter, was administered on days 1, 8, and 15,and cisplatin, at a dose of mg per square meter, was admin-istered on day 1 of a four-week cycle.
Patients in the third groupreceived 75 mg of docetaxel per square meter and 75 mg of cis-platin per square meter on day 1 of a three-week cycle. Those inthe fourth group were treated with mg of paclitaxel per squaremeter, given over a three-hour period on day 1, followed on thesame day by carboplatin at a dose calculated to produce an area PPROXIMATELY one third of all cancer-related deaths are due to lung cancer, whichaccounts for more deaths each year thanbreast, prostate, and colon cancer com-bined.
The median survival of patients with untreat-ed metastatic non—small-cell lung cancer is onlyfour to five months, with a survival rate at one yearof only 10 percent.
Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer.
Gogal In conclusion, docetaxel has markedly impacted the treatment of advanced NSCLC and continued evaluation in earlier-stage disease is warranted. Aftersome advantage of chemotherapy versus supportive care alone has been shown not only with platinum-based combination chemotherapy [ ] but also with many new cytotoxic agents e. The original sample size was significantly larger, but the trial was stopped early when the interim analysis showed a significant benefit to the experimental arm in terms of improved overall survival. N Engl J Med ; These are important studies to compare because they were conducted at nearly the same time and in very similar though not identical patient populations. Furthermore, there is an undeniable demand for specific treatment by patients and their relatives: Overall survival was the primary endpoint of this study. The relative merits of each of these end points may vary depending on the stages of NSCLC being treated i. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer.
Fesho The results of several large phase III studies are reviewed below. Median age of patients enrolled in randomised clinical trials is often significantly lower than that observed in clinical practice [ ], and eligibility criteria request good renal, hepatic and cardiac function, as well as absence of other significant co-morbidities. PS2 patients reported the worst scores at baseline assessment. Lung Cancer Highlights Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: This raises the eecog of whether time to progression will ultimately become the most important measure in NSCLC trials rather than survival. All these observations, as underlined by the authors, reinforce the perception that PS2 patients need special consideration when receiving chemotherapy. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the only therapeutic option.