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PubMed2000

Adjuvant CMF-chemotherapy and haemostasis. Effect of "classical" and "modified" adjuvant CMF-chemotherapy on blood coagulation fibrinolysis in patients with breast cancer.

Effects of "classical" and "modified" adjuvant CMF-chemotherapy on haemostasis were studied in 22 patients with breast cancer receiving cyclophosphamide (100 mg/m2 p.o.; days 1-14 or 600 mg/m2 i.v.; days 1,8), methotrexate (40 mg/m2 i.v.; days 1,8) and 5-fluorouracil (600 mg/m2 i.v.; days 1,8). Blood collection was done prior to chemotherapy on day 1 and 8. A significant decrease of protein C antigen and activity associated with cumulative effects was observed from day 1 to 8. This effect was similar with "classical" and "modified" CMF-chemotherapy but the reduction of protein C was more pronounced with the oral application of cyclophosphamide. In absence of any significant cumulative decrease of other vitamin K-dependent blood coagulation proteins (factor VII, protein S), the simultaneous decrease of protein C activity and antigen indicates a specific influence of CMF-chemotherapy on vitamin K-dependent protein C-synthesis in the liver.

Administration, Oral↗
PubMed2000

[Randomized comparative study of CMF (cyclophosphamide, methotrexate and 5-fluorouracil) and UFT-tamoxifen regimens as adjuvant chemotherapy after surgery for breast cancer: Tochigi Prefectural Study Group for Post-Breast Cancer Adjuvant Chemotherapy].

This prospective randomized study aimed at establishing the optimal postoperative adjuvant chemotherapy regimen for premenopausal n+ breast cancer patients. The treatments were Regimen A, comprising 6 courses of CMF (cyclophosphamide, 100 mg/body on days 1-14; methotrexate, 40 mg/m2 on days 1 and 8; and 5-fluorouracil, 500 mg/m2 on days 1 and 8), and Regimen B, consisting of UFT (300 mg/day) and tamoxifen (30 mg/day) administered orally each day for 2 years. Telephone registration allocated the patients to the treatment groups by the minimization method in relation to the T category, number of n+ lesions and estrogen receptor status. Forty-five patients were registered, and 44 of them were eligible (22 cases each to Regimen A and Regimen B). The principal background factors showed no biases between the groups. The adverse reaction incidence was significantly higher with Regimen A (90.9% vs 22.7%). The 5-year survival rate was 89.8% with Regimen A and 100% with Regimen B, while the 5-year disease-free rates were 64.5% and 76.3%, showing no statistical significance. Regimen B showed a better QOL rating after 6 months of therapy in relation to nausea-vomiting and hair loss, and after 24 months in relation to appetite, sleep, performance status, happiness, anorexia and hair loss.

Adult↗
PubMed1975

Adjuvant action of capsular polysaccharide of Klebsiella pneumoniae on antibody response. IV. The roles of antigen and adjuvant for induction of primary and secondary antibody responses and for development of immunological memory to bovine serum albumin.

A study was performed to clarify the roles of primary and secondary injections of antigen and adjuvant (capsular polysaccharide of Klebsiella pneumoniae, CPS-K) in induction of antibody responses and in the development of immunological memory in mice to bovine serum albumin (BSA). A primary injection of BSA alone neither induced significant primary antibody response nor increased immunological memory for a secondary antibody response but, if primary injections of BSA and CPS-K were performed simultaneously, high antibody responses were induced. Moreover, a prior injection of BSA alone or CPS-K alone decreased the level of primary antibody response and the degree of increase in memory following the subsequent injection of BSA mixed with CPS-K. In contrast, a secondary injection of BSA alone into mice once primed with a mixture of BSA and CPS-K elicited very high secondary type antibody response and increased secondarily the memory for a tertiary antibody response. Injection of CPS-K simultaneously with or shortly before or after the secondary injection of BSA did not increase the level of the secondary antibody response and the degree of the secondary increase in memory. Augmentation of the secondary antibody response was elicited by simultaneous injection of CPS-K only when the secondary response was induced inadequately by a suboptimum or supraoptimum dose of antigen.

Adjuvants, Immunologic↗
PubMed2006

[A randomized controlled trial to evaluate the effect of adjuvant oral fluoropyrimidine derivative therapy after curative resection for stage II/III rectal cancer-adjuvant chemotherapy trial of S-1 for rectal cancer (ACTS-RC):].

We are conducting a prospective randomized trial to evaluate the survival benefit of adjuvant chemotherapy with S-1 (tegafur, gimeracil, oteracil potassium) and UFT (uracil-tegafur) after curative surgery for patients with Stage II and III rectal cancer. Patients are randomized to either administration of UFT (control) or S-1. UFT was orally administered for 5 days (400 mg/m2/day) followed by two days rest for a year. S-1 was orally administered for 4 weeks (80 mg/m2/day) followed by two weeks rest for a year. The primary endpoint is relapse-free survival (RFS) rate, and the secondary endpoints are overall survival time (OS) and frequency or level of adverse events. We aim to include 400 patients in each of the treatment groups and assume that the registration period will last until 2009.

Antimetabolites, Antineoplastic↗
PubMed2006

Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial.

We evaluated the contribution of an epirubicin-based adjuvant chemotherapy on disease-free survival (DFS) in poor prognosis, node-negative breast cancer (BC) patients. Poor prognostic factors were defined as: pathologic tumor size >or= 4 cm, estrogen-receptor negative, and progesterone-receptor negative. Scarff-Bloom Richardson grade 2 tumors must have two of these factors, and only one in case of grade 3. Between 1988 and 1994, 328 patients were randomized to receive either no systemic treatment (control, n = 161), or fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2), 6 cycles every 21 days (FEC50, n = 167), without any hormonal treatment. The median follow up was 114 months. The 10-year DFS rates were 64 and 71%, respectively (p = 0.23). In the Cox regression model, independent prognostic factors of relapse were the number of nodes examined < 10 (p = 0.002), BCS (p = 0.01), and premenopausal status (p = 0.04). In this model, the relative risk of relapse was 1.46 (CI95 %: 1.05-1.87) in favor of FEC50. In patients who underwent BCS, 21 % developed a local relapse (24 versus 18 %, respectively). The 10-year local DFS was 70.5 and 79.3 %, respectively (p = 0.27). The 10-year overall survival was not different (74.1 versus 70.7 %, p = 0.82). After 10 years of follow-up, the FEC50 regimen reduced the risk of relapse in poor-prognosis node-negative BC patients. The incidence of local relapse was high, and probably related to inclusion criteria. Epirubicin was probably underdosed in such patients, and ongoing studies using 100 mg/m(2) of epirubicin will give us the answer in a near future.

Adult↗
PubMed1988

[Prospective adjuvant chemotherapy of mitomycin C plus HCFU for colorectal cancer (2d report)--6-year survival after surgery: Tokai Cooperative Study Group of Surgical Adjuvant Chemotherapy].

A prospective randomized controlled trial of adjuvant chemotherapy for colorectal cancer was performed in forty-one institutions in Tokai district. In this study, effect of postoperative administration of mitomycin C (MMC) and followed by HCFU for more than 3 months (group B) was on the survival time compared with MMC alone (group A). Of 173 patients subjected to curative resection (group A = 80, group B = 93) for colorectal cancer, 148 patients including 69 cases of group A and 79 cases of group B were eligible for survival study. At six years after surgery, Kaplan-Meire's life table showed that the survival of group B was superior to that of group A (generalized Wilcoxon test: p = 0.0446). The difference of survival curves was more distinct (generalized Wilcoxon test: p = 0.0226) for patients of advanced stage those to have lymph node metastasis time and serosal inversion.

Adjuvants, Immunologic↗
PubMed1988

The role of immunity to cartilage proteoglycan in adjuvant arthritis. Intravenous injection of bovine proteoglycan enhances adjuvant arthritis.

It has been suggested that autoimmunity to the proteoglycan (PG) component of cartilage plays a major role in the etiology of adjuvant arthritis (AA), which occurs in rats, but not in mice, after injection of CFA. In order to more directly investigate this role, bovine and human cartilage PG were used to modulate AA, and immunity to PG was assessed. Immunization of rats or mice with PG by itself does not induce arthritis. However, in rats, a single i.v. injection of soluble PG, given 1 wk before injection of CFA, results in a significant increase in incidence and severity of the arthritis induced. Rats injected with CFA have both antibody and delayed type hypersensitivity (DTH) to PG. Upon pretreatment of rats with PG i.v., both DTH and antibody titers to PG are increased. Rats immunized with PG in IFA have high titers of anti-PG and strong DTH to PG, which are also enhanced by pretreatment with PG i.v., although none of these animals develops arthritis. In contrast to these findings in rats, when mice are pretreated with PG i.v., DTH to PG induced by injection of CFA is lower, whereas anti-PG titers are higher than in unpretreated controls. The results presented here show that, in rats, i.v. injection of PG synergizes with CFA in the induction of AA, and enhances both humoral and cellular immunity to PG. The findings support the hypothesis that immunity to PG is of importance in AA, although under the conditions of these experiments immunity induced by PG alone is clearly not sufficient for the induction of arthritis.

Adjuvants, Immunologic↗
PubMed1979

[Interactions between macromolecular adjuvants and drugs. Part 17: On the effect of macromolecular adjuvants on the dissolution rate of chlorpromazine from dosage forms (author's transl)].

The determination of the dissolution rate of chlorpromazine from tablets and triturations containing macromolecular adjuvants by means of a modification of the flow-through type cell according to Langenbucher evidenced a decrease in the dissolution rate produced by polyvinylpyrrolidone, methyl-cellulose and hydroxyethyl-cellulose. It was found that the decrease in the dissolution rate is not due to the confirmed, relatively marked tendency of chlorpromazine to form complexes, but to gel formation.

Adjuvants, Pharmaceutic↗
PubMed1995

[Cooperative study of surgical adjuvant chemotherapy for colorectal cancer. Cooperative Study Group of Surgical Adjuvant Chemotherapy for Colorectal Cancer in Japan].

With the cooperation of 357 institutions nationwide, during the two years from January 1984 to December 1985, curative resection cases of colorectal cancer were divided into two groups and treated in the following method: A group with chemotherapy received MMC 12 mg/m2, on the day of operation, followed by 6 mg/m2 every two months, 6 times. From the second week after operation, 800 mg/body/day of FT was administered for one year. The other was a control group with operation only. In this study, targetting those cases in which recurrence was observed within 5 years, among eligible cases histologically curative resection, recurrence forms were examined by prognostic factors and usefulness of adjuvant chemotherapy after operation. Regarding the recurrence of liver metastasis, in the case of colon cancer, the effect of chemotherapy was observed in highly positive cases of lymph node metastasis and positive cases of lymphatic vessel invasion. In rectal cancer, it was noticed in Dukes C cases. For the local recurrence of rectal cancer, it was observed in Dukes C and cases of relative curative resection. Chemotherapy tended to inhibit recurrence within one year after the operation in both liver metastasis and local recurrence.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

[Neo-adjuvants, adjuvants and palliative therapy for gastric carcinoma].

Patients with gastric cancer have a poor prognosis. Because curative surgery is often impossible (metastatic disease) or extremely difficult (locally advanced tumors), and the majority of patients undergoing curative resection relapse, chemotherapy has been actively studied in gastric cancer. Several combination chemotherapy regimens have been developed with high activity in locally advanced and metastatic disease. Among them are 5-fluorouracil (5-FU) plus high dose methotrexate plus doxorubicin (FAMTX). It represents the reference treatment in many clinical trials. Recent schedules like etoposid plus cisplatin (EAP); etoposid plus leucovorin plus 5-FU (ELF) and epirubicin plus cisplatin plus 5-FU (ECF) show encouraging response rates, their toxicity is considerable, however. Randomized trials comparing chemotherapy with best supportive care showed an increase in overall survival and in quality-of-life. Up to now adjuvant chemotherapy has failed to improve survival as compared with surgical controls. Only half of the patients with locally advanced gastric cancer (LAGC) undergo macroscopic and microscopic tumor-free resection. Preoperative chemotherapy has shown very promising results even in patients who had primarily unresectable tumors. Approximately half undergo R0 resection after downstaging induced by active chemotherapy and the long-term survival rises to about 20%. There are hopes that the newest regimes may do this: new cytostatic drugs and the immuno-chemical approach to combine cytostatic drugs with cytokines will be of great importance.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Evaluation of the worth of corynebacterium parvum in conjunction with chemotherapy as adjuvant treatment for primary breast cancer. Eight-year results from the National Surgical Adjuvant Breast and Bowel Project B-10.

During the 1970s, information obtained from animal tumor models and from patients with a spectrum of solid tumors indicated the worth of a variety of immunostimulating agents. These findings provided a biological and clinical rationale for conducting randomized trials to evaluate the worth of those agents. Consequently, in May 1977 the National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented a randomized trial to determine whether Corynebacterium parvum (C. parvum, CP) plus chemotherapy would be more effective than chemotherapy alone in prolonging the disease-free survival (DFS) and survival (S) of patients with primary operable breast cancer and positive axillary nodes. The results of that trial through 8 years of follow-up fail to indicate that treatment with CP used in conjunction with l-phenylalanine mustard (L-PAM) plus 5-fluorouracil (PF) results in a better DFS and S than that observed after chemotherapy alone. Use of the immunomodulator has instead resulted in a poorer, but not statistically significant, outcome. Despite adjustments made to account for any imbalance in distribution of prognostic factors between the two treatment groups and despite considering treatment compliance as a factor, the unfavorable outcome persisted. A high incidence of fever and chills was associated with the administration of CP. The administration of hydrocortisone before each CP treatment reduced the frequency of those and other systemic effects. The failure to demonstrate a benefit from CP is in keeping with the failure of other nonspecific stimulating agents to contribute to the creation of a new paradigm for the treatment of breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1993

Pathologic findings from the National Surgical Adjuvant Breast Project (Protocol 4). Discriminants for 15-year survival. National Surgical Adjuvant Breast and Bowel Project Investigators.

Twenty-one pathologic and five clinical features of Stage I and II invasive breast cancers from 620 patients enrolled in National Surgical Adjuvant Breast Project Protocol B-04 were analyzed to determine their predictive value for 15-year survival. Ten pathologic features had a statistically significant univariate prognostic relationship with long-term survival. These were analyzed further using a Cox regression model that found only the number of nodal metastases (0, 1-3, 4-9, or 10+), tumor size (< or = 2.0 cm versus 2.1-4 and 4.1 + cm), and the presence or absence of nipple involvement to be significant independent prognostic discriminants. Combinations of these three characteristics modestly increased their individual prognostic value. Differences in the findings in this study from those observed in the same patient population at 5 and 10 postoperative years and their relationship to other markers detected by ancillary pathologic techniques briefly are discussed.

Aged↗
PubMed1995

Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) Protocol B-17. Intraductal carcinoma (ductal carcinoma in situ). The National Surgical Adjuvant Breast and Bowel Project Collaborating Investigators.

BACKGROUND: Controversy exists concerning the natural history of ductal carcinoma in situ (DCIS) of the breast, including its pathologic expression and treatment. This controversy has been fostered largely by the retrospective nature and limited sample sizes of extant studies. METHOD: Resolution of some of these issues was attempted by analyzing the pathologic features of 573 examples of DCIS obtained from a larger cohort of 790 women with DCIS enrolled in Protocol B-17 of the National Surgical Adjuvant Breast Project. This prospective randomized clinical trial was performed to assess the efficacy of local breast irradiation to reduce the incidence of second ipsilateral breast tumors (IBT) after lumpectomy. RESULTS: Tumor and patient characteristics, including significantly less IBT for those treated by lumpectomy and irradiation than lumpectomy alone, were almost identical for the subset comprising this analysis and the total B-17 cohort reported previously. The presence of moderate/marked comedo necrosis, which was evaluated as an independent parameter rather than as a specific histologic type of DCIS and uncertain/involved lumpectomy margins were the only statistically significant independent predictors of IBT for patients treated by lumpectomy as well as irradiation. The latter markedly reduced the annual hazard rates for the IBT associated with these indicators. CONCLUSIONS: Although not an endpoint of this study, the authors' findings suggest that the beneficial effect of irradiation in reducing IBT after lumpectomy for DCIS occurs with small (< 1.0 cm.) and larger lesions. Moderate/marked comedo necrosis and uncertain/involved lumpectomy margins represent independent predictors of IBT.

Adult↗
PubMed1994

The Role of Chemoendocrine Agents in Postoperative Adjuvant Therapy for Breast Cancer: Meta-analysis of the First Collaborative Studies of Postoperative Adjuvant Chemoendocrine Therapy for Breast Cancer (ACETBC).

The first collaborative studies of postoperative adjuvant chemoendocrine therapy for breast cancer (ACETBA) were carried out in 6 regions of Japan from 1982 to 1985, and the results were subjected to meta-analysis. Subjects consisted of stage II and IIIa cases who underwent radical mastectomy with Brt + Ax or more extensive resection for primary breast cancer. Regimen A consisted of tegafur (Futraful:FT) alone at 600 mg/day, and regimen B of FT at 600 mg/day with tamoxifen (TAM) at 20 mg/day. The duration of the treatment was one year in the Tohoku and Kinki regions, and 2 years in the other 4 regions. Meta-alalysis by Peto's method showed an odds reduction of 20+/- 7% (logrank test: P = 0.0069) for the 5-year overall survival rate in 4740 eligible patients, and 25 +/- 6%(logrank test: P <0.0001)for the 5-year disease-free survival rate. The odds reductions were both statistically significant, indicating that the adjuvantchemoendocrine therapy was effective. Subset analysis of data on 5-year disease-free survival showed that FT plus TAM therapy was better in ER-positive and post-menopausal patients, whether axillary lymph nodes were positive or negative.

Journal Article↗
PubMed1996

A randomized trial comparing ftorafur alone with ftorafur plus tamoxifen in postoperative adjuvant therapy for breast cancer. Kinki Area Research Group for Postoperative Adjuvant Therapy for Breast Cancer.

A randomized study was performed in 35 centers in the Kinki area of Japan to determine the effectiveness of ftrorafur (FT) plus tamoxifen (TAM) compared with FT monotherapy in postoperative adjuvant therapy for breast cancer. Patients were randomized by the envelope method to receive either FT 600 mg/day or FT 600 mg/day plus TAM 20 mg/day orally for 1 year, starting on day 7 after mastectomy. Between April 1982 and January 1985, 628 patients were assigned to treatment with FT alone and 626 to treatment with FT + TAM. Of these, 571 (90.9%) and 539 (86.1%) patients, respectively, met the eligibility requirements for this study. There were no significant differences in major background factors between the two groups of eligible patients. Five-year survival rates were 91.4% for FT alone and 91.1% for FT+TAM (not significantly different). Five-year disease-free survival rates showed a tendency towards a better prognosis (P = 0.090) in the FT + TAM group, with observed rates of 83.0% for FT alone and 86.7% for FT + TAM. Stratified analysis showed that disease-free survival with FT + TAM is better than with FT alone for patients aged 50 years or more ( P = 0.048) and for patients with from one to three positive nodes (P = 0.064).

Adult↗
PubMed1988

Cyclophosphamide and tamoxifen as adjuvant therapies in the management of breast cancer. CRC Adjuvant Breast Trial Working Party.

In 1980 the Cancer Research Campaign launched a multi-centre breast cancer trial; aimed at repeating the Scandinavian Chemotherapy Study Group's cyclophosphamide trial, and the NATO tamoxifen study; thereby further evaluating the role of these two adjuvant regimens in patients with early breast cancer. Two thousand two hundred and thirty women were randomized into this trial between 1980 and 1985 and preliminary analyses demonstrate a significant improvement in event-free survival for both regimens. Results from this study closely parallel the two trials it set out to repeat.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Controlled trial of tamoxifen as a single adjuvant agent in the management of early breast cancer. 'Nolvadex' Adjuvant Trial Organisation.

At a maximum follow up of 8 years (median 5 years 6 months) in a randomised trial of adjuvant tamoxifen versus no treatment as therapy for early breast cancer, a significant advantage persists for patients receiving 20 mg of tamoxifen daily for 2 years. This advantage is independent of menopausal status, stage, grade and ER status. Log hazard rate analysis fails to demonstrate a rebound effect on stopping the drug and suggests that more prolonged treatment might further improve results.

Breast Neoplasms↗