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Overview of the main outcomes in breast-cancer prevention trials. 12559863 2003 01 31 2003 02 12 2015 11 19 0140-6736 361 9354 2003 Jan 25 Lancet (London, England) Lancet Overview of the main outcomes in breast-cancer prevention trials. 296-300 Early findings on the use of tamoxifen or raloxifene as prophylaxis against breast cancer have been mixed; we update available data and overview the combined results. All five randomised prevention trials comparing tamoxifen or raloxifene with placebo (...) were included. Relevant data on contralateral breast tumours and side-effects were included from an overview of adjuvant trials of tamoxifen versus control. The tamoxifen prevention trials showed a 38% (95% CI 28-46; p<0.0001) reduction in breast-cancer incidence. There was no effect for breast cancers negative for oestrogen receptor (ER; hazard ratio 1.22 [0.89-1.67]; p=0.21), but ER-positive cancers were decreased by 48% (36-58; p<0.0001) in the tamoxifen prevention trials. Age had no apparent
Intrahepatic arterial versus intravenous fluorouracil and folinic acid for colorectal cancer liver metastases: a multicentre randomised trial. 12573372 2003 02 07 2003 03 07 2016 11 24 0140-6736 361 9355 2003 Feb 01 Lancet (London, England) Lancet Intrahepatic arterial versus intravenous fluorouracil and folinic acid for colorectal cancer liver metastases: a multicentre randomised trial. 368-73 The liver is the most frequent site for metastases of colorectal cancer, which is the second largest (...) contributor to cancer deaths in Europe. We did a randomised trial to compare an intrahepatic arterial (IHA) fluorouracil and folinic acid regimen with the standard intravenous de Gramont fluorouracil and folinic acid regimen for patients with adenocarcinoma of the colon or rectum, with metastases confined to the liver. We randomly allocated 290 patients from 16 centres to receive either intravenous chemotherapy (folinic acid 200 mg/m2, fluorouracil bolus 400 mg2 and 22-h infusion 600 mg/m2, day 1 and 2
Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. 12944571 2003 08 28 2003 09 03 2013 11 21 1533-4406 349 9 2003 Aug 28 The New England journal of medicine N. Engl. J. Med. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. 859-66 Despite aggressive local therapy, patients with locally advanced bladder cancer are at significant risk for metastases. We evaluated the ability (...) of neoadjuvant chemotherapy to improve the outcome in patients with locally advanced bladder cancer who were treated with radical cystectomy. Patients were enrolled if they had muscle-invasive bladder cancer (stage T2 to T4a) and were to be treated with radical cystectomy. They were stratified according to age (less than 65 years vs. 65 years or older) and stage (superficial muscle invasion vs. more extensive disease) and were randomly assigned to radical cystectomy alone or three cycles of methotrexate
Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. 12853587 2003 07 10 2003 07 14 2014 11 20 1533-4406 349 2 2003 Jul 10 The New England journal of medicine N. Engl. J. Med. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. 146-53 Patients with cancer have a substantial risk of recurrent thrombosis despite the use of oral anticoagulant therapy (...) . We compared the efficacy of a low-molecular-weight heparin with that of an oral anticoagulant agent in preventing recurrent thrombosis in patients with cancer. Patients with cancer who had acute, symptomatic proximal deep-vein thrombosis, pulmonary embolism, or both were randomly assigned to receive low-molecular-weight heparin (dalteparin) at a dose of 200 IU per kilogram of body weight subcutaneously once daily for five to seven days and a coumarin derivative for six months (target
High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. 12840087 2003 07 03 2003 07 08 2013 11 21 1533-4406 349 1 2003 Jul 03 The New England journal of medicine N. Engl. J. Med. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. 7-16 The use of high-dose adjuvant chemotherapy for high-risk primary breast cancer is controversial. We studied its efficacy in patients with 4 to 9 or 10 or more tumor-positive axillary lymph nodes (...) . Patients younger than 56 years of age who had undergone surgery for breast cancer and who had no distant metastases were eligible if they had at least four tumor-positive axillary lymph nodes. Patients in the conventional-dose group received fluorouracil, epirubicin, and cyclophosphamide (FEC) every three weeks for five courses, followed by radiotherapy and tamoxifen. The high-dose treatment was identical, except that high-dose chemotherapy (6 g of cyclophosphamide per square meter of body-surface area
Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell transplantation in high-risk breast cancer. 12840088 2003 07 03 2003 07 08 2013 11 21 1533-4406 349 1 2003 Jul 03 The New England journal of medicine N. Engl. J. Med. Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell transplantation in high-risk breast cancer. 17-26 The prognosis for women with primary breast cancer and 10 or more involved axillary (...) lymph nodes is poor. High-dose chemotherapy with autologous hematopoietic stem-cell transplantation has been reported to be effective in the adjuvant setting for patients at high risk for relapse. We randomly assigned 540 female patients with primary breast cancer and at least 10 involved ipsilateral axillary lymph nodes to receive either six cycles of adjuvant chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil (CAF) or the same adjuvant chemotherapy followed by high-dose chemotherapy
A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. 12621132 2003 03 06 2003 03 17 2014 11 20 1533-4406 348 10 2003 Mar 06 The New England journal of medicine N. Engl. J. Med. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. 883-90 Experimental studies in animals and observational studies in humans suggest that regular aspirin use may decrease the risk of colorectal adenomas (...) , the precursors to most colorectal cancers. We conducted a randomized, double-blind trial to determine the effect of aspirin on the incidence of colorectal adenomas. We randomly assigned 635 patients with previous colorectal cancer to receive either 325 mg of aspirin per day or placebo. We determined the proportion of patients with adenomas, the number of recurrent adenomas, and the time to the development of adenoma between randomization and subsequent colonoscopic examinations. Relative risks were adjusted
Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial. 12824205 2003 06 25 2003 07 08 2016 10 17 1538-3598 289 24 2003 Jun 25 JAMA JAMA Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial. 3243-53 The Women's Health Initiative trial of combined estrogen plus progestin was stopped early when overall (...) health risks, including invasive breast cancer, exceeded benefits. Outstanding issues not previously addressed include characteristics of breast cancers observed among women using hormones and whether diagnosis may be influenced by hormone effects on mammography. To determine the relationship among estrogen plus progestin use, breast cancer characteristics, and mammography recommendations. Following a comprehensive breast cancer risk assessment, 16 608 postmenopausal women aged 50 to 79 years
The influence of finasteride on the development of prostate cancer. 12824459 2003 07 17 2003 07 22 2014 06 09 1533-4406 349 3 2003 Jul 17 The New England journal of medicine N. Engl. J. Med. The influence of finasteride on the development of prostate cancer. 215-24 Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5alpha-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce (...) the risk of prostate cancer. In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal
Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. 12826431 2003 06 26 2003 07 17 2015 11 19 1474-547X 361 9375 2003 Jun 21 Lancet (London, England) Lancet Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. 2099-106 Despite improvements in the treatment of ovarian cancer, most (...) patients develop recurrent disease within 3 years of diagnosis. There is no agreed second-line treatment at relapse. We assessed paclitaxel plus platinum chemotherapy as such treatment. In parallel international, multicentre, randomised trials, between January, 1996, and March, 2002, 802 patients with platinum-sensitive ovarian cancer relapsing after 6 months of being treatment-free were enrolled from 119 hospitals in five countries. Patients were randomly assigned paclitaxel plus platinum chemotherapy
Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. 12867608 2003 07 17 2003 07 22 2016 10 19 1533-4406 349 3 2003 Jul 17 The New England journal of medicine N. Engl. J. Med. Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. 247-57 Colon cancers with high-frequency microsatellite instability have clinical and pathological features (...) that distinguish them from microsatellite-stable tumors. We investigated the usefulness of microsatellite-instability status as a predictor of the benefit of adjuvant chemotherapy with fluorouracil in stage II and stage III colon cancer. Tumor specimens were collected from patients with colon cancer who were enrolled in randomized trials of fluorouracil-based adjuvant chemotherapy. Microsatellite instability was assessed with the use of mononucleotide and dinucleotide markers. Of 570 tissue specimens, 95 (16.7
A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. 12904519 2003 08 07 2003 08 13 2007 03 27 1533-4406 349 6 2003 Aug 07 The New England journal of medicine N. Engl. J. Med. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. 546-53 Although numerous studies have shown that the status of the sentinel node is an accurate predictor of the status of the axillary nodes in breast cancer, the efficacy (...) and safety of sentinel-node biopsy require validation. From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group). The number of sentinel nodes found was the same in the two groups
A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. 12890841 2003 07 31 2003 08 04 2016 11 24 1533-4406 349 5 2003 Jul 31 The New England journal of medicine N. Engl. J. Med. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. 427-34 Mutations in the tumor-suppressor gene VHL cause oversecretion of vascular endothelial growth factor by clear-cell renal carcinomas. We (...) conducted a clinical trial to evaluate bevacizumab, a neutralizing antibody against vascular endothelial growth factor, in patients with metastatic renal-cell carcinoma. A randomized, double-blind, phase 2 trial was conducted comparing placebo with bevacizumab at doses of 3 and 10 mg per kilogram of body weight, given every two weeks; the time to progression of disease and the response rate were primary end points. Crossover from placebo to antibody treatment was allowed, and survival was a secondary
Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. 14519708 2003 10 01 2003 10 07 2016 10 17 1538-3598 290 13 2003 Oct 01 JAMA JAMA Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. 1739-48 The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously (...) in a randomized trial setting. To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures. Randomized, double-blind, placebo-controlled trial of 16 608 postmenopausal women, who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 (average follow-up, 5.6 years). One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone
Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. 14575968 2003 10 24 2004 01 05 2015 06 16 1474-547X 362 9392 2003 Oct 18 Lancet (London, England) Lancet Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. 1255-60 Anaemia is associated with poor cancer control, particularly in patients undergoing radiotherapy (...) . We investigated whether anaemia correction with epoetin beta could improve outcome of curative radiotherapy among patients with head and neck cancer. We did a multicentre, double-blind, randomised, placebo-controlled trial in 351 patients (haemoglobin <120 g/L in women or <130 g/L in men) with carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received curative radiotherapy at 60 Gy for completely (R0) and histologically incomplete (R1) resected disease, or 70 Gy
A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. 14551341 2003 11 06 2003 11 10 2014 11 20 1533-4406 349 19 2003 Nov 06 The New England journal of medicine N. Engl. J. Med. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. 1793-802 In hormone-dependent breast cancer, five years of postoperative tamoxifen therapy--but not tamoxifen therapy (...) of longer duration--prolongs disease-free and overall survival. The aromatase inhibitor letrozole, by suppressing estrogen production, might improve the outcome after the discontinuation of tamoxifen therapy. We conducted a double-blind, placebo-controlled trial to test the effectiveness of five years of letrozole therapy in postmenopausal women with breast cancer who have completed five years of tamoxifen therapy. The primary end point was disease-free survival. A total of 5187 women were enrolled
Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. 14645636 2003 12 03 2003 12 08 2013 11 21 1533-4406 349 22 2003 Nov 27 The New England journal of medicine N. Engl. J. Med. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. 2091-8 Induction chemotherapy with cisplatin plus fluorouracil followed by radiotherapy is the standard alternative to total laryngectomy for patients with locally advanced laryngeal (...) cancer. The value of adding chemotherapy to radiotherapy and the optimal timing of chemotherapy are unknown. We randomly assigned patients with locally advanced cancer of the larynx to one of three treatments: induction cisplatin plus fluorouracil followed by radiotherapy, radiotherapy with concurrent administration of cisplatin, or radiotherapy alone. The primary end point was preservation of the larynx. A total of 547 patients were randomly assigned to one of the three study groups. The median
Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. 14570950 2003 10 22 2003 10 24 2016 11 24 1538-3598 290 16 2003 Oct 22 JAMA JAMA Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. 2149-58 More persons in the United States die from non-small cell lung cancer (...) (NSCLC) than from breast, colorectal, and prostate cancer combined. In preclinical testing, oral gefitinib inhibited the growth of NSCLC tumors that express the epidermal growth factor receptor (EGFR), a mediator of cell signaling, and phase 1 trials have demonstrated that a fraction of patients with NSCLC progressing after chemotherapy experience both a decrease in lung cancer symptoms and radiographic tumor shrinkages with gefitinib. To assess differences in symptomatic and radiographic response
Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial. 12583944 2003 02 13 2003 03 21 2015 06 16 0140-6736 361 9356 2003 Feb 08 Lancet (London, England) Lancet Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial. 457-64 Policies of UK clinicians regarding the duration of chemotherapy for patients with advanced colorectal cancer (...) events than those in the continuous group. There was no clear evidence of a difference in overall survival (hazard ratio 0.87 favouring intermittent, 95% CI 0.69-1.09, p=0.23). Our findings provided no clear evidence of a benefit in continuing therapy indefinitely until disease progression. They showed that it is safe to stop chemotherapy after 12 weeks and re-start the same treatment on progression in patients with chemosensitive advanced colorectal cancer. Maughan T S TS Department of Oncology
Dietary fibre and colorectal adenoma in a colorectal cancer early detection programme. 12737857 2003 05 09 2003 05 29 2016 11 24 0140-6736 361 9368 2003 May 03 Lancet (London, England) Lancet Dietary fibre and colorectal adenoma in a colorectal cancer early detection programme. 1491-5 Although dietary fibre has been reported to have no association with colorectal adenoma and cancer, in some studies this topic remains controversial. We used a 137-item food frequency questionnaire to assess (...) the relation of fibre intake and frequency of colorectal adenoma. The study was done within the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomised controlled trial designed to investigate methods for early detection of cancer. In our analysis, we compared fibre intake of 33971 participants who were sigmoidoscopy-negative for polyps, with 3591 cases with at least one histologically verified adenoma in the distal large bowel (ie, descending colon, sigmoid colon, or rectum