Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Feb 1995
Randomized Controlled Trial Multicenter Study Clinical TrialRadiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer.
Regionally advanced, surgically unresectable non-small-cell lung cancer represents a disease with an extremely poor prognosis. External-beam irradiation to the primary tumor and regional lymphatics is generally accepted as standard therapy. The use of more aggressive radiation regimens and the addition of cytotoxic chemotherapy to radiotherapy have yielded conflicting results. Recently, however, results from clinical trials using innovative irradiation delivery techniques or chemotherapy before irradiation have indicated that patients treated with protocols that incorporate these modifications may have higher survival rates than patients receiving standard radiation therapy. ⋯ In "good-risk" patients with surgically unresectable non-small-cell lung cancer, induction chemotherapy followed by irradiation was superior to hyperfractionated radiation therapy or standard radiation therapy alone, yielding a statistically significant short-term survival advantage.
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J. Natl. Cancer Inst. · May 1994
Randomized Controlled Trial Multicenter Study Clinical TrialSector resection with or without postoperative radiotherapy for stage I breast cancer: five-year results of a randomized trial. Uppsala-Orebro Breast Cancer Study Group.
The effectiveness of routine postoperative irradiation following breast-conserving treatment of breast cancer has not previously been assessed in randomized clinical trials that have taken place in settings where mammography has been a major pathway to diagnosis or that have followed patients treated surgically by sector resection. ⋯ The increase in recurrence rate observed over time suggests that surgical technique and patient selection should be improved. The benefits of reduced cost and patient inconvenience that would result from the elimination of postoperative radiotherapy must be carefully weighed against the disadvantages of local recurrence. Longer term follow-up must be done to estimate the risk of cancer recurrence in these women 10 and 15 years later, and methods must be developed to identify those women who have a higher risk of recurrence. Finally, economic analyses of this and similar trials are needed to give empirical underpinnings for optimal use of radiotherapy.
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J. Natl. Cancer Inst. · Apr 1994
Randomized Controlled Trial Multicenter Study Clinical TrialEndometrial cancer in tamoxifen-treated breast cancer patients: findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14.
Tamoxifen is advantageous in treating all stages of breast cancer. However, studies have suggested that incidence and severity of endometrial cancer increase in women treated with tamoxifen. ⋯ Tamoxifen treatment for breast cancer should continue. In addition, the relative risk of endometrial cancer observed in B-14 tamoxifen-treated patients is consistent with the twofold relative risk used in the initial risk-benefit computation for the NSABP breast cancer prevention trial.
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J. Natl. Cancer Inst. · May 1993
Randomized Controlled Trial Multicenter Study Clinical TrialRecombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy.
Patients with advanced cancer frequently experience clinically significant anemia, which is often exacerbated by myelosuppressive chemotherapy. Consistent with the anemia of chronic disease, studies have documented serum erythropoietin levels that are inappropriately low for the degree of anemia in cancer patients. Myelosuppressive chemotherapy impairs erythropoiesis, which may not fully recover between treatment cycles. Recombinant human erythropoietin (rHuEPO) has been used safely and effectively to treat anemia in AIDS patients receiving zidovudine (AZT) and in patients with chronic renal failure. ⋯ We conclude that rHuEPO is safe and effective for reversing anemia related to advanced cancer or to chemotherapy for cancer.
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J. Natl. Cancer Inst. · Mar 1993
Multicenter StudyThe European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.
In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. ⋯ These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.