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PubMed1984

Pretreatment with antigen or adjuvant, and the preventability of allergic encephalomyelitis induced by basic protein with synthetic muramyl dipeptide in comparison with Freund's complete adjuvant.

Protection against experimental allergic encephalomyelitis (EAE) was examined by prior injection of following materials with Freund's incomplete adjuvant (FIA), Mycobacterium tuberculosis (Tbc), synthetic muramyl dipeptide (Mdp), polyinosinate-polycytidylate (poly IC), or myelin basic protein (BP). 26 days later, guinea pigs received encephalitogenic challenge in the form of 20 micrograms BP + 20 micrograms Tbc in FIA (BP + Tbc) or 20 micrograms BP + 10 micrograms Mdp in FIA (BP + Mdp). (1) Either pretreatment with Mdp, poly IC or FIA alone showed no protecting effects. (2) Tbc/FIA was not effective on challenge with BP + Mdp, but effective on challenge with BP + Tbc, and produced passive hemagglutinating (PH) antibodies of moderate titer and and complement fixing (CF) antibodies of higher titer. (3) BP/FIA was effective on both BP + Tbc and BP + Mdp challenges, and produced PH antibodies of higher titer than that of CF antibodies. (4) Clinicopathological survey revealed that the challenge with BP + Mdp was blocked perfectly by prior injection with BP/FIA whereas the challenge with BP + Tbc was incompletely blocked by either Tbc/FIA or BP/FIA pretreatment. (5) The finding was verified also by cerebrospinal fluid cell count at the termination of clinical observation. As compared with FCA, Mdp adjuvant itself has no antigenic component, which seems to explain the results in this study.

Acetylmuramyl-Alanyl-Isoglutamine↗
PubMed1980

Stimulation of the in vivo dinitrophenyl antibody response to the DNP conjugate of L-glutamic acid60-L-alanine30-L-Tyrosine10 (GAT) polymer by a synthetic adjuvant, muramyl dipeptide (MDP): target cells for adjuvant activity and isotypic pattern of MDP-stimulated response.

Specific anti-dinitrophenyl (DNP) response to DNP-conjugated L-glutamine60-L-alanine30-L-tyrosine10 (DNP-GAT) was obtained in GAT-responder mice by using synthetic N-acetylmuramyl-L-alanyl-D-isoglutamine (MDP) as adjuvant. Significant levels of anti-DNP antibodies were observed during a secondary response to DNP-GAT, when both antigen and MDP were used for priming. In this system, MDP was able to prime the carrier-specific T cells but not the hapten specific B cells. The study of the isotypic pattern of the anti-DNP response shows that MDP stimulates only the appearance of specific anti-DNP IgG1 plaque-forming cells. Anti-DNP plaque-forming cells were stimulated in animals primed with DNP-GAT in Freund's complete adjuvant or in Maalox-pertussis and used as control IgG1, IgG2a, and IgG2b.

Acetylmuramyl-Alanyl-Isoglutamine↗
PubMed1981

Mechanisms of the adjuvant effect of hemoglobin in experimental peritonitis. IV. The adjuvant effect of hemoglobin in granulocytopenic rats.

Intraperitoneal inocula of pure Escherichia coli do not produce lethal peritonitis unless adjuvant materials are present. We have previously presented evidence that hemoglobin acts as an adjuvant in experimental Escherichia coli peritonitis by interfering with antibacterial neutrophil function. The hypothesis was further tested in normal Sprague-Dawley rats and rats depleted of granulocytes by pretreatment with busulfan and cyclophosphamide. Hemoglobin increased the lethality of Escherichia coli peritonitis in both neutropenic and normal rats. Furthermore, the early clearance of bacteria from the peritoneal cavity was equally depressed by hemoglobin in neutropenic and normal rats. We conclude that hemoglobin has some effect on intraperitoneal infections beyond its suppression of granulocyte function. This additional effect may represent interference with bacterial lymphatic absorption or peritoneal or systemic macrophage function or may be a manifestation of a nutritional effect of hemoglobin on bacterial growth.

Adjuvants, Immunologic↗
PubMed1995

A randomized trial of postoperative adjuvant chemotherapy in non-small cell lung cancer (the second cooperative study). The Study Group of Adjuvant Chemotherapy for Lung Cancer (Chubu, Japan).

A prospective randomized trial (the second cooperative study) was conducted from July 1985 to December 1987 to investigate the benefits of postoperative adjuvant chemotherapy in patients for whom non-small cell lung cancer had been resected completely. Patients were randomly assigned either to a chemotherapy group (group A) treated postoperatively with CDDP (66 mg/m2 x 1), ADM (26 mg/m2 x 1) and UFT (8 mg/kg/day) during 6 months, or to a control group (group B) which had undergone surgery only. Three hundred and thirty-three resected cases were registered. Among them, 24 cases (7.2%) were excluded, because of incomplete resection (15), pathologically benign tumour (3), small cell lung cancer (2) and other factors (4). Three hundred and nine cases were eligible: 155 cases in group A (p-Stage I 93, II 19, III 43) and 154 in group B (I 109, II 10, III 35). The 5-year survival rate in group A was 61.8%, and that in group B 58.1%. The 5-year disease-free survival rate for each group was 61.8% and 57.4%, respectively. There were no significant differences in the 5-year survival between the two groups. However, since a significant difference was observed between the two groups regarding pathological lymph node metastasis (pN), the prognostic factors were adjusted using Cox's proportional hazard model. Thereafter the adjusted survival rate and disease-free survival rate for group A became significantly higher than for group B (P = 0.044 and P = 0.036, respectively). Thus, from these results, it is concluded that the role of surgery for non-small cell lung cancer still remains of primary importance, and postoperative adjuvant chemotherapy is effective to improve the results of surgery and prolong life of patients with non-small cell lung cancer.

Adult↗
PubMed1975

The mode of action of mycobacterial adjuvants. III. The clonal nature of antibody formation and the effect of mycobacterial adjuvant on antibody-forming cell clones.

Localization of 19S and 7S plaque forming cells detected by Jerne plaque technique were examined in the spleens of irradiated recipient mice transferred with a limiting number of spleen cells and SRBC. All the plaques within a single colony were homogeneous in size and appearance. This supports the clonal nature of antibody formation. An addition of a mycobacterial adjuvant, wax D, to the sensitizing antigen, SRBC, caused an increase in the number of clones (colonies) developing large plaques. It is suggested that there may be normally available competent precursors for clones developing large plaques and the precursors may specifically increase in number in the presence of the adjuvant.

Adjuvants, Immunologic↗
PubMed1990

Adjuvant chemotherapy with 5-fluorouracil, vincristine and CCNU for patients with Dukes' C colorectal cancer. The Swedish Gastrointestinal Tumour Adjuvant Therapy Group.

A prospective controlled randomized trial testing adjuvant postoperative combination chemotherapy (5-fluorouracil, lomustine (CCNU) and vincristine) versus no adjuvant therapy in patients operated on for Dukes' C colorectal cancer is reported. In total 334 patients aged less than 70 years were recruited: 205 patients with colonic and 99 with rectal cancer, but there were three protocol violations and these cases are excluded from further consideration. Twenty-seven patients had a limited resection of their cancer. After 5 years' follow-up there was no significant difference in the tumour-free survival rate or in the survival rate between the treated and control groups. Twenty-nine of the 147 patients who started chemotherapy discontinued this treatment because of side-effects, mainly from the gastrointestinal tract. In 30 patients treatment was discontinued because of recurrent disease. The conclusion is that systemic administration of combination chemotherapy for colorectal cancer after operation is not worthwhile in routine clinical practice.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1980

Serial CEA levels in colorectal carcinoma on adjuvant immuno(chemo)therapy--further follow-up. Modulation of adjuvant treatment.

Serial plasma CEA levels have been studied preoperatively (testing A); one day after surgery (B); 10--15 days after surgery (C); 4 (D), 8 (E), 12 (F), 16--18 (G), and 22--24 (H) months after surgery in a series of 45 patients affected by colorectal carcinoma who started soon after surgery a protocol of adjuvant immuno(chemo)therapy with Levamisole and BCG. Postoperative follow-up was from one to 26 months, with 28 patients followed for at least one year. Fourteen patients had recurrences: two of these had false-negative CEA tests, three had persistent high CEA levels after surgery, nine had increasing levels 9--12 months before clinical recurrence; and nine of these 14 patients showed frankly pathologic preoperative plasma CEA levels. Six patients who did not have a recurrence but (both at clinical and instrumental evaluation) who had two consecutive high plasma CEA levels, were put on prophylactic polichemotherapy. The prognostic importance of CEA levels both pre- and postoperatively, the possibility of "modulating" postoperative adjuvant treatments on the basis of CEA levels, and the problem of unexplained fluctuations of plasma CEA levels with the putative metabolic linkages are discussed.

Adult↗
PubMed1999

Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma.

BACKGROUND: Bulky stage IB cervical cancers have a poorer prognosis than smaller stage I cervical cancers. For the Gynecologic Oncology Group, we conducted a trial to determine whether weekly infusions of cisplatin during radiotherapy improve progression-free and overall survival among patients with bulky stage IB cervical cancer. METHODS: Women with bulky stage IB cervical cancers (tumor, > or =4 cm in diameter) were randomly assigned to receive radiotherapy alone or in combination with cisplatin (40 mg per square meter of body-surface area once a week for up to six doses; maximal weekly dose, 70 mg), followed in all patients by adjuvant hysterectomy. Women with evidence of lymphadenopathy on computed tomographic scanning or lymphangiography were ineligible unless histologic analysis showed that there was no lymph-node involvement. The cumulative dose of external pelvic and intracavitary radiation was 75 Gy to point A (cervical parametrium) and 55 Gy to point B (pelvic wall). Cisplatin was given during external radiotherapy, and adjuvant hysterectomy was performed three to six weeks later. RESULTS: The relative risks of progression of disease and death among the 183 women assigned to receive radiotherapy and chemotherapy with cisplatin, as compared with the 186 women assigned to receive radiotherapy alone, were 0.51 (95 percent confidence interval, 0.34 to 0.75) and 0.54 (95 percent confidence interval, 0.34 to 0.86), respectively. The rates of both progression-free survival (P<0.001) and overall survival (P=0.008) were significantly higher in the combined-therapy group at four years. In the combined-therapy group there were higher frequencies of transient grade 3 (moderate) and grade 4 (severe) adverse hematologic effects (21 percent, vs. 2 percent in the radiotherapy group) and adverse gastrointestinal effects (14 percent vs. 5 percent). CONCLUSIONS: Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.

Adult↗
PubMed1999

Outcomes among African-Americans and Caucasians in colon cancer adjuvant therapy trials: findings from the National Surgical Adjuvant Breast and Bowel Project.

BACKGROUND: African-Americans generally have lower survival rates from colon cancer than Caucasian Americans. This disparity has been attributed to many sources, including diagnosis at later disease stage and other unfavorable disease features, inadequate treatment, and socioeconomic factors. The randomized clinical trial setting ensures similarity in disease stage and a uniform treatment plan between blacks and whites. In this study, we evaluated survival and related end points for African-American and Caucasian patients with colon cancer participating in randomized clinical trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP) to determine whether outcomes were less favorable for African-Americans. METHODS: The study included African-American (n = 663) or Caucasian (n = 5969) patients from five serially conducted, randomized clinical trials of the NSABP. We compared recurrence-free survival, disease-free survival (recurrence, new primary cancer, or death), and survival (death from any cause) between blacks and whites by using statistical modeling to account for differences in patient and disease characteristics between the groups. Statistical tests were two-sided. RESULTS: Dukes' stage and number of positive lymph nodes were remarkably similar between African-American and Caucasian patients in each trial. Over all trials combined, an 8% (95% confidence interval [CI] = -6% to 25%; P =.27) excess risk of colon cancer recurrence that was not statistically significant was observed for blacks. A greater disparity in survival was seen, with blacks experiencing a statistically significant 21% (95% CI = 6%-37%; P =.004) greater risk of death. Treatment efficacy appeared similar between the groups. CONCLUSIONS: While the overall survival prognosis was less favorable for African-Americans compared with Caucasians in these trials, other outcomes measured were considerably more similar than those seen in the population at large, suggesting that earlier detection and adjuvant therapy could appreciably improve colon cancer prognosis for African-Americans. Continued investigations into causes of the deficits noted are warranted.

Adult↗
PubMed1990

Adjuvant therapy of Dukes' A, B, and C adenocarcinoma of the colon with portal-vein fluorouracil hepatic infusion: preliminary results of National Surgical Adjuvant Breast and Bowel Project Protocol C-02.

Between March 1984 and July 1988, 1,158 patients with Dukes' A, B, and C carcinoma of the colon were entered into National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol C-02. Patients were randomized to either no further treatment following curative resection or to postoperative fluorouracil (5-FU) and heparin administered via the portal vein. Therapy began on day of operation and consisted of constant infusion for 7 successive day. Average time on study was 41.8 months. A comparison between the two groups of patients indicated both an improvement in disease-free survival (74% v 64% at 4 years, overall P = .02) and a survival advantage (81% v 73% at 4 years, overall P = .07) in favor of the chemotherapy-treated group. When compared with the treated group, patients who received no further treatment had 1.26 times the risk of developing a treatment failure and 1.25 times the likelihood of dying after 4 years. Particularly significant was the failure to demonstrate an advantage from 5-FU in decreasing the incidence of hepatic metastases. The liver was the first site of treatment failure in 32.9% of 82 patients with documented recurrences in the control group and in 46.3% of 67 patients who received additional treatment. Therapy is administered via a regional route to affect the incidence of recurrence within the perfused anatomic boundary. Since, in this study, adjuvant portal-vein 5-FU infusion failed to reduce the incidence of hepatic metastases, it may be concluded that its use thus far is not justified. It may also be speculated that the disease-free survival and survival advantages (the latter of borderline significance) are a result of the systemic effects of 5-FU.

Adenocarcinoma↗
PubMed2004

Patterns of locoregional failure in patients with operable breast cancer treated by mastectomy and adjuvant chemotherapy with or without tamoxifen and without radiotherapy: results from five National Surgical Adjuvant Breast and Bowel Project randomized clinical trials.

PURPOSE: To assess patterns of locoregional failure (LRF) in lymph node-positive (LN+) breast cancer patients treated with mastectomy and adjuvant chemotherapy (+/- tamoxifen) and without postmastectomy radiotherapy (PMRT) in five National Surgical Adjuvant Breast and Bowel Project trials. PATIENTS AND METHODS: We examined 5,758 patients enrolled onto the B-15, B-16, B-18, B-22, and B-25 trials. Median follow-up time was 11.1 years. Distribution of pathologic tumor size was < or = 2 cm, 2.1 to 5 cm, and more than 5 cm in 30%, 52%, and 11% of patients, respectively. Distribution of the number of LN+ was one to three, four to nine, and > or = 10 in 51%, 32%, and 16% of patients, respectively. Ninety percent of patients received doxorubicin-based chemotherapy. RESULTS: The overall 10-year cumulative incidences of isolated LRF, LRF with or without distant failure (DF), and DF alone as first event were 12.2%, 19.8%, and 43.3%, respectively. Cumulative incidences for LRF as first event with or without DF for patients with one to three, four to nine, and > or = 10 LN+ were 13.0%, 24.4%, and 31.9%, respectively (P < .0001). For patients with a tumor size of < or = 2 cm, 2.1 to 5.0 cm, and more than 5.0 cm, these incidences were 14.9%, 21.3%, and 24.6%, respectively (P < .0001). Multivariate analysis showed age, tumor size, premenopausal status, number of LN+, and number of dissected LN as significant predictors for LRF as first event. CONCLUSION: In patients with large tumors and four or more LN+, LRF as first event remains a significant problem. Although PMRT is currently recommended for patients with four or more LN+, it may also have value in selected patients with one to three LN+. However, in the absence of a randomized trial examining the worth of radiotherapy in this group of patients, the value of PMRT remains unknown.

Adult↗
PubMed2006

Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in five National Surgical Adjuvant Breast and Bowel Project node-positive adjuvant breast cancer trials.

PURPOSE: Locoregional failure after breast-conserving surgery is associated with increased risk of distant disease and death. The magnitude of this risk in patients receiving chemotherapy has not been adequately characterized. PATIENTS AND METHODS: Our study population included 2,669 women randomly assigned onto five National Surgical Adjuvant Breast and Bowel Project node-positive protocols (B-15, B-16, B-18, B-22, and B-25), who were treated with lumpectomy, whole-breast irradiation, and adjuvant systemic therapy. Cumulative incidences of ipsilateral breast tumor recurrence (IBTR) and other locoregional recurrence (oLRR) were calculated. Kaplan-Meier curves were used to estimate distant-disease-free survival (DDFS) and overall survival (OS) after IBTR or oLRR. Cox models were used to model survival using clinical and pathologic factors jointly with IBTR or oLRR as time-varying predictors. RESULTS: Four hundred twenty-four patients (15.9%) experienced locoregional failure; 259 (9.7%) experienced IBTR, and 165 (6.2%) experienced oLRR. The 10-year cumulative incidence of IBTR and oLRR was 8.7% and 6.0%, respectively. Most locoregional failures occurred within 5 years (62.2% for IBTR and 80.6% for oLRR). Age, tumor size, and estrogen receptor status were significantly associated with IBTR. Nodal status and estrogen and progesterone receptor status were significantly associated with oLRR. The 5-year DDFS rates after IBTR and oLRR were 51.4% and 18.8%, respectively. The 5-year OS rates after IBTR and oLRR were 59.9% and 24.1%, respectively. Hazard ratios for mortality associated with IBTR and oLRR were 2.58 (95% CI, 2.11 to 3.15) and 5.85 (95% CI, 4.80 to 7.13), respectively. CONCLUSION: Node-positive breast cancer patients who developed IBTR or oLRR had significantly poorer prognoses than patients who did not experience these events.

Adult↗
PubMed1993

Premenopausal patients with node-positive resectable breast cancer. Preliminary results of a randomised trial comparing 3 adjuvant regimens: FEC 50 x 6 cycles vs FEC 50 x 3 cycles vs FEC 75 x 3 cycles. The French Adjuvant Study Group.

Anthracyclines are among the most active drugs for the treatment of advanced breast cancer. Epirubicin has been found to be as effective as doxorubicin at equimolar doses but significantly better tolerated, especially in terms of alopecia, leucopenia, and cardiac toxicity. The role of anthracycline-containing regimens in adjuvant treatment of breast cancer has been studied by only a few clinical trial teams. In 1986, the French Adjuvant Study Group (FASG) began a randomised trial aimed to investigate the concept of dose intensity as well as the optimal duration of treatment in patients with early breast cancer. Between 1986 and 1990, 621 patients were included in the trial, of whom 595 were evaluable. Patients were randomised to 1 of 3 treatment groups: Group A (n = 207) received FEC 50 (fluorouracil 500 mg/m2, epirubicin 50 mg/m2 plus cyclophosphamide 500 mg/m2) every 21 days for 6 cycles; Group B (n = 193) received FEC 50 every 21 days for 3 cycles; Group C (n = 195) received FEC 75 (fluorouracil 500 mg/m2, epirubicin 75 mg/m2 plus cyclophosphamide 500 mg/m2) every 21 days for 3 cycles. Locoregional radiotherapy was administered after the third cycle of chemotherapy in all treatment arms. Clinical prognostic factors were similar between treatment groups. Approximately 62% of all patients had 1 to 3 positive lymph nodes; 50% of patients were hormone receptor positive and 73% were Scarff-Bloom Richardson (SBR) grade 2 to 3. Toxicity was evaluated in 595 patients (207, 193 and 195 patients in Groups A, B and C, respectively), who received a total of 2301 chemotherapy cycles.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

Prolonged adjuvant chemotherapy in breast cancer. The Scandinavian Adjuvant Chemotherapy Study 2.

Eleven hundred and sixteen primary female breast cancer patients received one short perioperative chemotherapy course. The node negative patients were randomised between immunotherapy (corynebacterium parvum s.c. around the scar 2 weeks after mastectomy), or no further adjuvant therapy. A moderate, but significant delaying effect was observed, without side effects. The node positive patients were randomised to four groups: 1) the same immunotherapy as in the node negative patients, 2) CMF for 1 year, 3) combination of these two treatments, or 4) no further adjuvant therapy. The prolonged chemotherapy had a significant positive effect, but also considerable and distressing side effects. The immunotherapy had a non-significant negative effect in the node positive patients, but without side effects.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Pilot study of postoperative adjuvant chemoradiation for advanced gastric cancer: adjuvant 5-FU/cisplatin and chemoradiation with capecitabine.

AIM: To evaluate the efficacy and toxicity of postoperative chemoradiation using FP chemotherapy and oral capecitabine during radiation for advanced gastric cancer following curative resection. METHODS: Thirty-one patients who had underwent a potentially curative resection for Stage III and IV (M0) gastric cancer were enrolled. Therapy consists of one cycle of FP (continuous infusion of 5-FU 1000 mg/m(2) on d 1 to 5 and cisplatin 60 mg/m(2) on d 1) followed by 4500 cGy (180 cGy/d) with capecitabine (1650 mg/m(2) daily throughout radiotherapy). Four wk after completion of the radiotherapy, patients received three additional cycles of FP every three wk. The median follow-up duration was 22.2 mo. RESULTS: The 3-year disease free and overall survival in this study were 82.7% and 83.4%, respectively. Four patients (12.9%) showed relapse during follow-up. Eight patients did not complete all planned adjuvant therapy. Grade 3/4 toxicities included neutropenia in 50.2%, anemia in 12.9%, thrombocytopenia in 3.2% and nausea/vomiting in 3.2%. Neither grade 3/4 hand foot syndrome nor treatment related febrile neutropenia or death were observed. CONCLUSION: These preliminary results suggest that this postoperative adjuvant chemoradiation regimen of FP before and after capecitabine and concurrent radiotherapy appears well tolerated and offers a comparable toxicity profile to the chemoradiation regimen utilized in INT-0116. This treatment modality allowed successful loco-regional control rate and 3-year overall survival.

Adult↗
PubMed1989

[Mitomycin C plus HCFU adjuvant chemotherapy for noncuratively resected cases of colorectal carcinoma. (Second report): 5-year survival rate. Cooperative Study Group of Kyushu and Chugoku for HCFU Adjuvant Chemotherapy].

In order to examine the efficacy of adjuvant chemotherapy employing mitomycin C (MMC) and carmofur (HCFU) for patients with noncuratively resected colorectal carcinoma, a cooperative study was performed by 54 institutions in the Kyushu and Chugoku areas of Japan. The criteria for patient selection were as follows: 1) Age of 75 years or less and not accompanied by any serious disease. 2) Macroscopic diagnosis as being noncuratively resected on completion of the surgical procedure. 3) Definitive diagnosis of colorectal carcinomas, histologically. 4) No synchronous or metachronous double cancer. The prospective randomized controlled study consisted of two groups. In Group A, the MMC group received bolus intravenous injections of 20 mg MMC on the day of operation and 10 mg the next day, followed by 10 mg every 4 weeks until a total of 100 mg had been administered. In Group B, the MMC + HCFU group received the same treatment in Group A, but with the addition of 600 mg/day of HCFU from the second week, orally for at least one year. Concerning the 69-month survival rate, a better result was observed in the MMC + HCFU group than in the MMC only group (generalized Wilcoxon test: p less than 0.05). Significantly better survival rates were obtained in those cases with disseminating peritoneal metastasis, hepatic metastasis and stage V cancer in the MMC + HCFU group as when compared with the MMC only group. No significant side effects due to the combined administration of HCFU were recognized. The combined administration of MMC and HCFU was suggested to be a safe and effective adjuvant chemotherapy for noncuratively resected cases of colorectal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

[Cooperative study of surgical adjuvant chemotherapy of colorectal cancer (first report): Investigation of background factors and adverse effects. Cooperative Study Group of Surgical Adjuvant Chemotherapy of Colorectal Cancer in Japan].

In order to evaluate the efficacy of surgical adjuvant chemotherapy in patients undergoing gross curative resection for colorectal cancer (excluding m and sm cancer), a randomized controlled study was conducted from January, 1982 to October, 1983. Four hundred and ninety-one institutions participated in this study. The schedules for drug administration differed according to each district. In the Hokkaido and Shikoku districts, the patients were divided into the following two groups, one was a combination of ACNU and Futraful (FT) and the other was FT only. In the Chubu and Kinki districts, three groups were studied, namely those receiving a combination of ACNU and FT, those receiving FT only and those given no adjuvant chemotherapy. In the Tohoku and Kanto districts, a combination of MMC and FT and administration of FT only were studied. In the Chugoku and Kyushu districts, the patients were divided into a combination of ADM and FT, and FT only group. Among the 3,926 registered cases, 3,421 cases were valid for the study. As to the background factors, there were no significant differences among the groups in each district. There were no significant differences in one-year survival rates and one-year disease-free rates. No serious adverse effects were observed in any of the groups.

Alopecia↗
PubMed1983

Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer. Interim analysis at four years by Nolvadex Adjuvant Trial Organisation.

Tamoxifen ('Nolvadex'), an anti-oestrogen, has been evaluated as an adjunct to the local treatment of early breast cancer in a prospective randomised clinical trial. 1285 women (with pathological stage II premenopausal and pathological stage I and II postmenopausal disease) were treated by total mastectomy with either axillary node clearance or axillary node sampling and then randomised to receive either tamoxifen 10 mg twice daily for two years or no further treatment. Treatment failure (recurrent disease or death) at 21 months was reduced in patients receiving tamoxifen (14 X 2%) compared with controls (20 X 5%) (p = 0 X 01). This is equivalent to a prolongation of the disease-free interval from 21 months to 30 months at the mean follow-up time of 21 months. Subgroup analyses by menopausal, axillary lymph node, and oestrogen receptor status did not reveal a significantly different treatment effect in any of these subgroups. There has been no significant effect on mortality at this point in the study. This endocrine adjuvant therapy was well tolerated and treatment was discontinued in only 14 (2 X 2%) patients as a direct result of side-effects. Thus, tamoxifen significantly delays recurrence in early breast cancer. The magnitude of the effect is comparable with that associated with adjuvant cytotoxic chemotherapy at a similar follow-up time, but with minimal toxicity and excellent compliance.

Breast Neoplasms↗