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At least 199 records · Page 11Linked to original sources
PubMed1998

Establishment of histological criteria for high-risk node-negative breast carcinoma for a multi-institutional randomized clinical trial of adjuvant therapy. Japan National Surgical Adjuvant Study of Breast Cancer (NSAS-BC) Pathology Section.

BACKGROUND: A multi-institutional randomized clinical trial of adjuvant therapy for patients with high-risk node-negative (n0) breast cancer has been undertaken in Japan. The pathology panel was organized in order to establish histological criteria to identify patient groups with higher rates of recurrence. METHODS: Initially, three pathologists independently judged the nuclear grade, composed of nuclear atypia and mitotic counts, of 100 n0 invasive ductal carcinomas, focusing on interobserver variation of the nuclear grade and its correlation with patient prognosis. These pathologists then gave consensus histological types and nuclear grades for 130 other n0 breast carcinomas and examined the prognostic significance of the grade. RESULTS: In the first study, nuclear grade 2-3 significantly identified a patient group with a rate of recurrence of 17-20% by any pathologists and the degree of agreement for the grade was fair. In the second study, the consensus type and nuclear grade identified a group (n = 66) with a 22% recurrence rate and another group (n = 64) with a 3.6% recurrence rate at 10 years. In 12 tumors, the resection-fixation interval of the tumor did not generate any significant difference in mitotic counts. CONCLUSIONS: The histological type and the nuclear grade clearly identified a higher-risk patient group with n0 breast carcinoma, and may be applied to the multi-institutional protocol study when the criteria have been well standardized by the pathologists.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

HER2 and choice of adjuvant chemotherapy for invasive breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15.

BACKGROUND: Recent retrospective analyses have suggested that breast cancer patients whose tumors overexpress HER2 derive preferential benefit from treatment with anthracyclines such as doxorubicin. This has led some clinicians to propose that HER2 should be used as a predictive marker in choosing between anthracycline-based regimens and combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil (CMF). We evaluated this recommendation in a retrospective study of National Surgical Adjuvant Breast and Bowel Project Protocol B-15, in which patients received a combination of doxorubicin and cyclophosphamide (AC), CMF, or AC followed by CMF. We hypothesized that AC would be superior to CMF only in the HER2-positive patients. METHODS: Immunohistochemical detection of HER2 was performed on tumor sections from 2034 of 2295 eligible patients. We used statistical analysis to evaluate the interaction between the efficacy of the assigned treatments and HER2 overexpression. All statistical tests were two-sided. RESULTS: Tumor sections from 599 patients (29%) stained positive for HER2. AC was superior to CMF in HER2-positive patients only, although differences in outcomes did not reach statistical significance. In the HER2-positive cohort, relative risks of failure (i.e., after AC treatment as compared with CMF treatment) were 0.84 for disease-free survival (DFS) (95% confidence interval [CI] = 0.65--1.07; P =.15), 0.82 for survival (95% CI = 0.63--1.06; P =.14), and 0.80 for recurrence-free survival (RFS) (95% CI = 0.62--1.04; P =.10). Tests for interaction between treatment and HER2 status were suggestive but not statistically significant (P =.19 for DFS, P =.11 for survival, and P =.08 for RFS). CONCLUSIONS: These results, together with overview results indicating minor overall superiority for anthracycline-based regimens relative to CMF, indicate a preference for the AC regimen in patients with HER2-positive tumors. Both AC and CMF regimens may be considered for patients with HER2-negative tumors.

Adult↗
PubMed1986

Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer: 5-year results from the National Surgical Adjuvant Breast and Bowel Project Trial.

In this National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial, 1,891 women with primary operable breast cancer and positive axillary nodes were randomized between Jan, 1977 and May 1980 to receive L-phenylalanine mustard (L-PAM) and 5-fluorouracil (5-FU) either with or without tamoxifen (TAM)-PFT. This report presents life table probabilities, cumulative odds ratios, and P values for disease-free survival (DFS) and survival at yearly intervals through 5 years of observation (mean time on study, 72 months). When patients were examined overall without regard for any discriminant associated with outcome, ie, age, number of positive nodes, or tumor receptor status, there was a significant prolongation of DFS (P = .002), but not survival through the fifth postoperative year. The benefit was almost entirely restricted to those greater than or equal to 50 years with greater than or equal to 4 positive nodes. In that group there was a 66% greater chance of remaining disease free if PFT was received (P less than .001), and there was also a significant survival benefit (P = .02). The advantage from PFT was found to be associated with tumor estrogen receptor (ER) and progesterone receptor (PR) as well as patient age and nodal status. Overall there was a significant improvement in DFS from PFT in those having tumors with an ER or PR level greater than or equal to 10 femtomole (fmol) (P = .01 and .009, respectively). No significant benefit in DFS or survival has been observed in patients less than or equal to 49 years old related either to nodes or tumor receptor status. Survival continues to be adversely affected by TAM in those patients (less than or equal to 49 years old), particularly when their tumors have a PR of 0 to 9 fmol (P = .007). In patients greater than or equal to 50 years old with four or more positive nodes, a significant DFS benefit persisted through the fifth year of observation in those having tumor ER or PR levels greater than 10 fmol (P less than .001 and .002). The advantage was observed in patients 50 to 59 years old as well as those 60 to 70. Women in the older decade demonstrated some advantage from PFT when their tumor ER or PR was 0 to 9 fmol. The most likely explanation for this finding is analytical error in receptor analyses.(ABSTRACT TRUNCATED AT 400 WORDS)

Aged↗
PubMed2004

Disease-free survival advantage of weekly epirubicin plus tamoxifen versus tamoxifen alone as adjuvant treatment of operable, node-positive, elderly breast cancer patients: 6-year follow-up results of the French adjuvant study group 08 trial.

PURPOSE: To assess whether an epirubicin (EPI) -based chemotherapy plus hormonal regimen improves disease-free (DFS) in women older than 65 years, with node-positive, operable breast cancer (BC), relative to tamoxifen (TAM) alone. PATIENTS AND METHODS: A total of 338 patients were randomly assigned after surgery to receive TAM 30 mg/d for 3 years (TAM, n = 164), or EPI 30 mg on days 1, 8, and 15 every 28 days for six cycles plus TAM 30 mg/d for 3 years (EPI-TAM, n = 174). In both arms, patients received radiotherapy, delivered after chemotherapy (CT) in the EPI-TAM group. RESULTS: The 6-year DFS rates were 69.3% with TAM and 72.6% with EPI-TAM (P = .14). The multivariate analysis shows a relative risk of relapse of 1.93 (95% CI, 1.70 to 2.17) with TAM compared with EPI-TAM (P = .005). The 6-year OS, related to disease progression, was 79.1% and 79.8%, respectively (P = .41). Compliance with CT was good: 96.9% of patients received six cycles. The acute toxicity per patient was mild: grade 2 neutropenia in 5.9%, grade 2 anemia in 2.0%, grade 3 nausea or vomiting in 4.6%, and grade 3 alopecia in 7.2%. Five cases (in five patients) of decreased left ventricular ejection fraction occurred after CT: three after adjuvant CT, and two after anthracycline-based CT for relapse. One patient died as a result of dysrhythmia related to carcinomatous lymphangitis. No secondary leukemia occurred. CONCLUSION: This study conducted in node-positive elderly patients demonstrates a significant contribution of a weekly EPI regimen in terms of DFS. Moreover, this regimen is safe for hematologic, nonhematologic, and cardiac toxicities.

Age Factors↗
PubMed2003

Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.

PURPOSE: To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases. PATIENTS AND METHODS: In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma. RESULTS: The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively). Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS. Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS. Interferon-related toxicities were modest: grade 3 (and in only one case, grade 4) fatigue or mood disturbance was seen in 7% and 4% respectively, of patients. However, there were 50 withdrawals (15%) from interferon treatment due to toxicity. CONCLUSION: The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.

Adolescent↗
PubMed1988

Adjuvant treatment of postmenopausal patients with high risk primary breast cancer. Results from the Danish adjuvant trials DBCG 77 C and DBCG 82 C.

The efficacy of adjuvant treatment with tamoxifen was evaluated in protocol DBCG 77 C. Postmenopausal high risk patients (tumor greater than 5 cm, positive axillary nodes, or invasion to skin/fascia) were randomized after total mastectomy and axillary sampling to postoperative radiotherapy (control) or to radiotherapy plus treatment with tamoxifen (TAM), 30 mg daily for 1 year. A total of 1,716 patients entered the study. At 8 years of follow-up, (7 years median time of observation), we observed a significant increase of recurrence-free survival for the TAM treated group and a reduction in mortality, which is significant for patients less than 70 years of age. Retrospectively, an increased recurrence-free survival in TAM treated patients was significant in the following subgroups: tumor less than 5 cm, positive lymph nodes, anaplasia grade II and estrogen receptor level greater than 100 fmol/mg cytosol protein. In the subsequent trial (DBCG 82 C), 1,347 postmenopausal patients less than 70 years were randomized to one of the following 3 regimens: radiotherapy + tamoxifen, 30 mg daily for 1 year (TAM), TAM alone, or TAM + CMF (CMF i.v. day 1 every 4 weeks x 9). The survival is similar in the 3 groups at 4 years (2 years median time of observation).

Aged↗
PubMed1989

Perioperative adjuvant chemotherapy in breast cancer. The Scandinavian Adjuvant Chemotherapy Study 1.

In a randomized study of operable primary breast cancer patients initiated January 1965, 507 patients received one single course with cyclophosphamide 5 mg/kg/day for six days, first dose given immediately after mastectomy. The 519 control patients received no adjuvant chemotherapy. In other respects both groups were treated equally. Median follow-up time is 17.1 years. In terms of relapse-free percentage, the difference between the groups after 20 years is 13.5% in favour of the cyclophosphamide group. The difference is statistically highly significant. This benefit is observed in node positive as well as in node negative patients, and over as well as under 50 years. The immediate side effects of the cyclophosphamide course have been very moderate. No late complications have been observed. In a parallel randomized study with 110 patients where the same course was given 2-4 weeks after mastectomy, no benefit could be observed.

Aged↗
PubMed1991

[Cooperative study of surgical adjuvant chemotherapy for colorectal cancer (third report): five-year results. Cooperative Study Group of Surgical Adjuvant Chemotherapy for Colorectal Cancer in Japan].

A randomized controlled study was carried out by the envelope method with 491 institutions in participation across the country in order to find an optimal surgical adjuvant chemotherapy for curatively resected colorectal cancer. The schedules for drug administration were different in four districts: ACNU + Futraful (FT) group and FT alone group in the Hokkaido-Shikoku district; the same schedule groups plus untreated group in the Chubu-Kinki district; MMC+FT group, FT alone group in the Tohoku-Kanto district; and ADM+FT group and FT alone group in the Chugoku-Kyushu district. The numbers of patients admitted to this study were 2,450 cases with colon cancer and 2,456 cases met the evaluation criteria of this study. The 5-year survival rate on the whole did not differ from combination therapy to single drug therapy in either colon cancer or rectal cancer, but in Dukes C rectal cancer the five-year survival rate tended to be higher with the combination therapies. In n2 (+) or a2(s) rectal cancer in particular, combination therapies with MMC and FT and with ADM and FT achieved significantly higher five-year survival rate, and the rate of local recurrence was significantly lower with ADM+FT.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

[Treatment with UFT as surgical adjuvant chemotherapy in carcinoma of large intestine. Cooperative Study Group of Surgical Adjuvant Chemotherapy for Colorectal Cancer in Japan].

The therapeutic results of the method II of the second study of the Cooperative Study Group of Surgical Adjuvant Chemotherapy for Colorectal Cancer in Japan were retrospectively reviewed and the relations of the 3-year survival rate to the dose of UFT per body weight as well as per kg of the patient and discontinuation of the treatment with UFT were investigated. The dose per day of UFT was randomly divided into group C (treated with UFT 600 mg/body/day) and group D (treated with UFT 400 mg/body/day for 12 months) by the envelope method. The 3-year survival rate of the patients whose body weight was 50 kg or more was higher than in the patients weighting less than 50 kg. The 3-survival rate of the patients treated with UFT from 8 to less than 12 mg/kg was the highest, while that of the patients treated with UFT of more than 12 mg/kg was the lowest. However, no statistical difference was observed between the two groups. The same results were observed in carcinoma of the colon and rectum, respectively. The findings indicated that the administration of excess amount of UFT was not effective. The relation between the 3-year survival rate and discontinuation of treatment with UFT was investigated at 6, 9 and 12 months after administration with UFT. The prognostic background factors of the C-group and the D-group were compared, but no difference was observed between the 2 groups at 9 months after administration. The 3-year survival rate of the patients treated continuously with UFT was higher than that of discontinued administration. The difference was especially evident in carcinoma of the colon, and good results were observed in cases treated continuously than in discontinued cases in both C- and D-groups.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

[Cooperative study of surgical adjuvant chemotherapy of colorectal carcinoma (second study): a preliminary report. Cooperative Study Group of Surgical Adjuvant Chemotherapy of Colorectal Cancer in Japan].

In a prospectively randomized study, the effect of adjuvant chemotherapy with mitomycin C (MMC) and tegafur (FT) on survival and recurrence was analyzed in 2,477 evaluable patients with colon or rectal cancer who underwent macroscopically curative resection. Patients (1,256 with colon cancer, 1,221 with rectal cancer) were divided into the treatment group (group A) and the control group (surgical resection only, group B). In group A, chemotherapy consisted of intravenous administration of MMC (12 mg/m2 on operative day, followed by 6 mg/m2/2 months, 6 times) and oral administration of FT (800 mg/day for one year). No serious adverse effects were observed in the treatment group. There was no significant difference between group A and group B in three-year survival rate. The disease-free interval curve in group A of rectal cancer revealed significantly better results than group B (p = 0.044). There was no difference in the incidence of local recurrence at three years after operation between group A and group B. The incidence of metachronous liver metastases in group A of rectal cancer was significantly lower than in group B (p = 0.036).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

[Cooperative study of surgical adjuvant chemotherapy of colorectal carcinoma (second study): 3-year survival after surgery of non-curatively resected patients. Cooperative Study Group of Surgical Adjuvant Chemotherapy of Colorectal Cancer in Japan].

A prospective randomized study was carried out to evaluate the efficacy of surgical adjuvant chemotherapy for non-curatively resected colorectal carcinoma patients as a collaborative study at 428 institutes in Japan from Jan., 1984 to Dec., 1985. A total of 1,138 patients were entered in this study. All patients were divided according to disease location (colon or rectum) and received one of two chemotherapeutic regimens after surgery (Regimen C: MMC 12 mg/m2 i.v. at operation day and 6 mg/m2 in every 2 months +UFT 600 mg/day p.o., D: the same dose of MMC + UFT 400 mg/day p.o.) randomly. 556 cases (colon carcinoma regimen C: 148, D: 185 cases, rectal carcinoma regimen C: 94, D: 129 cases) were evaluable at this presentation. Three-year-survival rate of histologically confirmed non-curatively resected colon carcinoma patients was higher in the group receiving regimen C than in regimen D. But no significant difference was found among the other groups.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1985

Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer. Analysis at six years by Nolvadex Adjuvant Trial Organisation.

A randomised controlled trial of tamoxifen as a single adjuvant agent after mastectomy for early breast cancer, reported on at an average follow-up of almost 2 years in 1983, has now been followed up to a maximum of 6 years. 1285 patients aged 75 or less were entered into the trial. Premenopausal women with positive axillary nodes and postmenopausal women with both positive and negative axillary nodes were randomised to receive either tamoxifen 10 mg twice daily for two years or to the untreated control group with systemic therapy reserved until the time of relapse. 46% of the trial population had primary tumour specimens assayed for oestradiol receptor (ER) content. There has been a highly significant prolongation of the disease-free interval in the tamoxifen-treated group followed by a highly significant reduction in death rate, with 45 (34%) fewer deaths observed in the treated group than in the control group. This benefit appeared to be independent of menopausal, nodal, or ER status.

Adult↗
PubMed1988

[A cooperative study of surgical adjuvant chemotherapy of colorectal cancer (second report): 3-year survival rate. Cooperative Study Group of Surgical Adjuvant Chemotherapy of Colorectal Cancer in Japan].

To evaluate the efficacy of surgical adjuvant chemotherapy for patients with curatively resected colorectal cancer (excluding m and sm cancer), a randomized controlled study was performed from January 1982 to October 1983. The schedules for drug administration were different in four districts, and four randomly assigned protocols were studied using tegafur (FT), ACNU, MMC and ADM. A total of 4,906 cases from 491 institutions were entered and 4,206 cases were varied for the study. There were no significant differences in 3-year survival rate in each district protocol. According to Dukes C for rectal cancer patients, ADM + FT group was higher than the FT only group in 3-year survival rate (p = 0.092) and had a significantly longer survival than FT only group in 3-year disease-free rate (p = 0.011). The rate of local recidivation in colon cancer resected curatively was higher in ACNU + FT group than in FT only group (p less than 0.05). A tendency for decreased liver metastasis was observed in FT group compared with the control group, and liver metastasis of ADM + FT group was lower than that of FT only group. No serious adverse effects were observed in any protocol.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

[Cooperative research on post-operative adjuvant therapy of breast cancer. Tohoku Society of Adjuvant Chemo-endocrine Therapy of Breast Cancer].

A randomized trial was carried out in 55 institutes in the Tohoku district to examine the significance of breast cancer post-operative adjuvant chemo-endocrine therapy in stage II and IIIa patients for possible radical mastectomy. A total of 619 patients were entered from November 1982 to November 1984, of whom 554 were eligible. Patients were administered MMC 13 mg/m2 after surgery, and randomized using the envelope method into either group A, treated with Tegafur 400 mg/m2 alone (275 patients), or group B, treated with Tegafur 400 mg/m2 and Tamoxifen 20 mg/daily (279 patients), for a year from the 7th day after operation. There was no significant difference between the two groups in the background factors of age, menopausal status, operation methods, stage or number of positive lymph nodes, but there were more patients of ER(+) in group B. A Kaplan-Meier method comparison showed no significant difference between the two groups in 3-year disease-free survival rates. There was no significant difference between the two groups compared by ER or menopausal status. However, patients with 4 or more positive lymph nodes showed a significant benefit in group B. Group B also marked a higher disease-free survival rate for ER(+) patients with 4 or more positive lymph nodes.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Adjuvant chemotherapy in the treatment of colon cancer: randomized multicenter trial of the Italian National Intergroup of Adjuvant Chemotherapy in Colon Cancer (INTACC).

BACKGROUND: To determine whether the addition of leucovorin to the combination 5-fluorouracil plus levamisole prolongs disease-free survival and overall survival in patients with radically resected colon cancer (Dukes' B(2-3) and C). PATIENTS AND METHODS: Patients (1703) were accrued between March 1992 and February 1995 in a large-scale clinical trial within five Italian cooperative groups. After stratification for center, patients were randomized as follows: arm A, 5-fluorouracil [450 mg/m(2) intravenous (i.v.) bolus on days 1-5] and levamisole (150 mg orally for 3 days, every 14 days for 6 months) versus arm B, 6-S-leucovorin (100 mg/m(2) i.v. bolus on days 1-5) followed by 5-fluorouracil (370 mg/m(2) i.v. bolus on days 1-5), plus levamisole (as arm A), every 4 weeks for six cycles. RESULTS: After a median follow-up of 6.4 years no significant difference was seen for either disease-free survival (58% versus 60%, not significant) or 5-year overall survival (68% versus 71%, not significant), respectively. Gastrointestinal toxicity (World Health Organization grade 3/4) was more frequent in arm B (8% versus 18%, not significant). CONCLUSIONS: In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer.

Adult↗