The Safety and Therapeutic Effect Analysis of Intraoperative Intraperitoneal Chemotherapy with Lobaplatin for Hepato-Biliary-Pancreatic Cancer

2020 ◽  
Author(s):  
Gang Chen ◽  
Hao Chen ◽  
Qifan Zhang ◽  
Siyun Zhang ◽  
Huanyu Li ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Disease Free Survival ◽  
Control Group ◽  
Study Group ◽  
Free Survival ◽  
Significant Difference ◽  
Liver And Kidney ◽  
Intraperitoneal Perfusion ◽  
Disease Free

Abstract Background To examine the safeness and efficacy of intraoperative intraperitoneal perfusion chemotherapy with lobaplatin on hepato-biliary-pancreatic cancer. Methods Clinical data were retrospectively collected from a total of 66 patients with HBP cancer undertaken surgeries. They were divided into two groups: the study (lobaplatin) group (33 patients) and the control group (33 patients). The disease-free survival rate, postoperative complications, and chemotherapy side effects (bone marrow, liver, and kidney toxicity) were analyzed to examine the safeness and efficacy of intraoperative intraperitoneal chemotherapy with lobaplatin. Results In the study group, two patients had a postoperative subphrenic infection and increased peritoneal effusion, one patient had postoperative leukopenia and thrombocytopenia, while the control group had postoperative abnormal coagulation function in 1 patient, and gastrointestinal bleeding in 1 patient, no significant difference in postoperative complication was observed between the two groups. There was no significant difference in the liver and kidney function between the two groups after surgery (p > 0.05). A total of 26 patients in the two groups had recurrence or metastasis within one year after surgery, including eight patients in the study group and 18 patients in the control group. The recurrence rate of hepatocellular cancer in the lobaplatin group and control was 21.14% and 60%, respectively (P = 0.012 < 0.05). But there was no significant difference in the disease-free survival function analysis (P = 0.127 > 0.05). Conclusions Intraperitoneal perfusion chemotherapy with lobaplatin is a safe and effective treatment in the process of radical resection of hepato-biliary-pancreatic tumors, which has therapeutic potential in reducing postoperative tumor recurrence and metastasis.

Preoperative hepatic and regional arterial chemotherapy in the prevention of liver metastasis after colorectal cancer surgery

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4090-4090
Author(s):  
J. Xu ◽  
Y. Zhong ◽  
W. Niu ◽  
X. Qin ◽  
Y. Wei ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Liver Metastasis ◽  
Disease Free Survival ◽  
Stage Ii ◽  
Stage Iii ◽  
Control Group ◽  
Free Survival ◽  
Significant Difference ◽  
Disease Free

4090 Background: To investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection. Methods: Patients with Stage II or Stage III colorectal cancer (CRC) were randomly assigned to receive preoperative hepatic and regional arterial chemotherapy (PHRAC group, n=256) or surgery alone (control group, n=253). The primary endpoint was disease-free survival, whereas the secondary endpoints included liver metastasis-free survival and overall survival. Results: There were no significant differences in overall morbidity between PHRAC and Control groups. During the follow-up period (median, 42 months), the median liver metastasis time for patients with stage III CRC was significantly longer in the PHRAC group (16±3 months v.s. 8±1 months, P=0.01). In stage III patients, there was also significant difference between the two groups with regard to the incidence of liver metastasis (18.9% vs 27.3%, P=0.01), 5-year disease-free survival (70.2% vs 52.0%, P=0.0076), 5-year overall survival (80.3% vs 69.5%, P=0.020) and the median survival time (40.1± 4.6 months vs 36.3 ± 3.2 months, P=0.03). In the PHRAC arm, the risk ratio of recurrence was 0.63 (95% CI, 0.51–0.79, P=0.0001), of death was 0.50(95% CI, 0.32–0.67; P=0.005), and of liver metastasis was 0.70 (95% CI, 0.52–0.86; p=0.01). In contrast, PHRAC seemed to be no benefit for stage II patients. Toxicities, such as hepatic toxicity and leucocyte decreasing, were mild and could be cured with medicine. Conclusions: Preoperative hepatic and regional arterial chemotherapy, in combination with surgical resection, could be able to reduce and delay the occurrence of liver metastasis and therefore improve survival rate in patients with stage III colorectal cancer. No significant financial relationships to disclose.

scholarly journals Laparoscopic extralevator abdominoperineal extirpation of the rectum: long-term results

2020 ◽  
Vol 10 (3-4) ◽  
pp. 34-42
Author(s):  
M. A. Danilov ◽  
A. V. Leontyev ◽  
A. B. Baychorov ◽  
Z. M. Abdulatipova ◽  
G. G. Saakyan
Keyword(s):  
Neoadjuvant Chemoradiotherapy ◽  
Disease Free Survival ◽  
Main Group ◽  
Long Term Results ◽  
Control Group ◽  
Free Survival ◽  
Significant Difference ◽  
Oncological Results ◽  
Disease Free

Objective: comparative assessment of long-term oncological results of laparoscopic extralevator and traditional abdominal-perineal resection (APR).Materials and methods. The analysis of immediate and long-term oncological results of treatment of 92 patients who underwent traditional laparoscopic and extralevator APR for low rectal cancer. Inclusion criteria were tumors of the lower ampullar rectum, excluding the performance of sphincter-sparing surgical interventions, and patients’ age up to 75 years. Exclusion criteria: distant metastases, histologically confirmed squamous cell carcinoma. Analysis of immediate and long-term results was carried out.Results. The main group included patients who underwent extralevator APR (n = 62), patients in the control group (n = 30) underwent traditional APR. There were no significant differences in the type of neoadjuvant and adjuvant treatment in the comparison groups (p >0.05). In the group of patients operated on in the volume of extralevator APR, 42 received neoadjuvant chemoradiotherapy versus 19 patients in the group of traditional APR, there was no statistically significant difference (p = 0.21). In the extralevator APR group, perineal plastic surgery was performed significantly more often than in the traditional APR group (p = 0.001). When evaluating the immediate results, there was a statistically significant difference in the total number of complications between the study groups, such complications as bladder dysfunction following after surgery, inflammatory pelvic disease in the perineal wound, perineal hernia occurred significantly more often in the traditional APR group than in the extralevator APR group (p >0.05). In terms of overall and disease-free survival, the groups differed statistically significantly: 5-year overall survival in the main group was 90 % versus 62.5 % in the control group (p = 0.03), 5-year disease-free survival in the main group was 98.5 % versus 65 % in the control group, respectively (p = 0.01).Conclusions. Extralevator APR of the rectum is the most radical surgical intervention than with the traditional APR technique due to the lower risk of a positive circumferention resection margin, therefore, reducing the incidence of local recurrence, and as a result, improving overall and disease-free survival rates compared to the traditional technique.

scholarly journals Interferon-a-2b As a Maintenance Therapy Significantly Improves Disease-Free Survival in Patients with Low-Risk Acute Myeloid Leukemia

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3823-3823
Author(s):  
Xiaohong Liu ◽  
Wenbing Duan ◽  
Jing Wang ◽  
Jinsong Jia ◽  
Lizhong Gong ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Myeloid Leukemia ◽  
Interferon Therapy ◽  
Disease Free Survival ◽  
Low Risk ◽  
Control Group ◽  
Consolidation Chemotherapy ◽  
Free Survival ◽  
Significant Difference ◽  
Disease Free

Background: Interferon-𝜶has a world-widely acknowledged anti-tumor activity and immunoregulatory function. Rare of the previous study reported significant efficacy of IFN-𝜶in AML (high, medium and low risk) patients. Although cytotoxic chemotherapy significantly improved the survival of low-risk AML, the reported low-risk AML 5-year OS was only 34-65%.Whether Interferon-𝜶-2b(IFN-𝜶-2b) could reduce recurrence and improve DFS in the maintenance therapy of low-risk AML subtypes has not been verified. The aim of this study was to evaluate the efficacy and safety of IFN-𝜶-2b in the maintenance of low-risk acute myeloid leukemia, in order to provide suggestions for clinical practice. Method: This study retrospectively analyzed 31 patients with low-risk AML who were treated with IFN-𝜶-2b maintenance therapy from March 2015 to March 2018 at the Peking University Institute of Hematology. The control group consisted of 1:1 matched 31 patients with low-risk AML. The pairing factors were age, gender, diagnostic time and subtype, induction and consolidation courses, and minimal residual disease (MRD) at the end of chemotherapy. Both groups of patients were AML patients who underwent 1-2 therapeutic induction chemotherapy for complete hematologic remission (CR) and completed 5-7 courses of consolidation chemotherapy. The interferon group was administered with 3 million U ofIFN-𝜶-2b three times a week; the control group was only observed and followed up after consolidation chemotherapy. We compared the treatment efficacy and prognostic improvement in low-risk AML by comparing MRD, disease-free survival (DFS), event-free survival (EFS), and overall survival (OS). Results: The median age of the 31 patients in the interferon group was 50 (21-67) years. Themolecular biological characteristicsof the interferon group were NPM1+/FLT3-ITD-8 cases; CEBPA double mutation 9 cases; CBFβ-MYH11+/C-KIT-5 cases; and ETO+/C-KIT- 9 cases. The median age of the control group was 44 (26-70) years old, and the molecular biological characteristics were paired with the interferon group. The median follow-up time of the 31 patients with low-risk AML in the interferon group and the control group was 14.5 (4-34) months and 16 (5.5-35) months, respectively. The median duration of treatment in the interferon group was 10(1-24) months. In interferongroup, patients with negative or positive MRD status were 16 and 15, respectively. Whereas, in control group, patients with negative or positive MRD status were 20 and 11, respectively. In interferon group, patients with original MRD, 10/15 (66.67%) showed MRD conversion after the median time of 5 (1-14.5) months IFN-𝜶-2b treatment, while in control group 3/11 (27.3%) of the patients showed MRD negative-positive conversion. There was a statistically significant difference in the rate of MRD conversion between the two groups (X2=3.939, P=0.047). The interferon group significantly decreased the rate of MRD compared with the control group. The conversion rate of the interferon group and the control group was (66.67%) vs (27.3%). In addition, the 2-year EFS of the interferon group was significantly higher than that of the control group (81.6±7.5) % vs (50.0±10.9) %, P=0.041(Figure 1.A). With refer to recurrence, 3 patients had hematologic recurrence in the interferon group, compared with 10 in the control group. Each group has 2 persistent MRD positive patients and MRD level increased more than 2 log-fold. 1 patient in control group had negative MRD converted to positive. The 2-year DFS of the interferon group was significantly higher than that of the control group (81.2±8.8)% vs (56.7±9.9)%, P=0.042 (Figure 1.B). There was no significant difference between the interferon group and the control group at 2 years of OS, which was (91.4±5.8)% vs (78.7±10.8)% (P=0.587) (Figure 1.C).In terms of safety, 24/31 (77.4%) had grade 1-2 fever after IFN-𝜶-2b therapy. 4/31 patients (12.9%) developed grade 3-4 hematologic toxicity, all of which were thrombocytopenia. Conclusion:IFN-𝜶-2b as maintenance therapyfor CR1 patients with low-risk AML significantly improved the rate of MRD conversion compared with patients without it. DFS and EFS were higher than those without it. Patients receiving interferon therapy have a low incidence of adverse reactions. Interferon therapy is safe and well-tolerated. Disclosures No relevant conflicts of interest to declare.

Adjuvant bacillus Calmette-Guérin therapy in non-Hodgkin's malignant lymphomas: long-term results of a randomized trial in a single institution.

1990 ◽  
Vol 8 (4) ◽  
pp. 608-614 ◽  
Author(s):  
A Ravaud ◽  
H Eghbali ◽  
M Trojani ◽  
G Hoerni-Simon ◽  
P Soubeyran ◽  
...  
Keyword(s):  
Overall Survival ◽  
Poor Prognosis ◽  
Disease Free Survival ◽  
Control Group ◽  
Bacillus Calmette Guerin ◽  
Free Survival ◽  
Significant Difference ◽  
Grade Malignancy ◽  
High Grade Malignancy ◽  
Disease Free

Between 1973 and 1977, 48 patients less than 65 years old with non-Hodgkin's malignant lymphoma (NHML) of poor prognosis (+/- high grade malignancy, +/- clinical stages III or IV, +/- first or repeated relapse) were included in a prospective clinical trial. After complete remission (CR), obtained with chemotherapy and radiotherapy, patients were randomized to receive bacillus Calmette-Guérin (BCG) or no further therapy. BCG was administered in weekly scarifications up to 3 years. Forty-three patients are assessable. Twenty-four patients have relapsed: nine out of 21 in the BCG group, and 15 out of 22 in the control group. There is a significant difference in favor of the BCG group in disease-free survival (P = .03). Twenty-one patients have died, 18 from NHML: seven in the BCG group, and 11 in the control group. There is a significant difference in favor of the BCG group for overall survival at 10 years (P = .05). A multivariate analysis points out BCG as a significant prognostic factor. Adjuvant BCG may improve particularly disease-free survival and overall survival for patients with clinical stages I and II or intermediate- and high-grade malignancy. These results suggest that in patients less than 65 years old with NHML of poor prognosis, BCG may significantly increase disease-free survival and overall survival.

scholarly journals Effect of platelet inhibition with perioperative aspirin on survival in patients undergoing curative resection for pancreatic cancer: a propensity score matched analysis

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
E. Pretzsch ◽  
J. G. D’Haese ◽  
B. Renz ◽  
M. Ilmer ◽  
T. Schiergens ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Propensity Score ◽  
Disease Free Survival ◽  
Hematogenous Metastasis ◽  
Control Group ◽  
Metastasis Formation ◽  
Free Survival ◽  
Positive Effects ◽  
Disease Free

Abstract Background The importance of platelets in the pathogenesis of metastasis formation is increasingly recognized. Although evidence from epidemiologic studies suggests positive effects of aspirin on metastasis formation, there is little clinical data on the perioperative use of this drug in pancreatic cancer patients. Methods From all patients who received curative intent surgery for pancreatic cancer between 2014 and 2016 at our institution, we identified 18 patients that took aspirin at time of admission and continued to throughout the inpatient period. Using propensity score matching, we selected a control group of 64 patients without aspirin intake from our database and assessed the effect of aspirin medication on overall, disease-free, and hematogenous metastasis-free survival intervals as endpoints. Results Aspirin intake proved to be independently associated with improved mean overall survival (OS) (46.5 vs. 24.6 months, *p = 0.006), median disease-free survival (DFS) (26 vs. 10.5 months, *p = 0.001) and mean hematogenous metastasis-free survival (HMFS) (41.9 vs. 16.3 months, *p = 0.005). Three-year survival rates were 61.1% in patients with aspirin intake vs. 26.3% in patients without aspirin intake. Multivariate cox regression showed significant independent association of aspirin with all three survival endpoints with hazard ratios of 0.36 (95% CI 0.15–0.86) for OS (*p = 0.021), 0.32 (95% CI 0.16–0.63) for DFS (**p = 0.001), and 0.36 (95% CI 0.16–0.77) for HMFS (*p = 0.009). Conclusions Patients in our retrospective, propensity-score matched study showed significantly better overall survival when taking aspirin while undergoing curative surgery for pancreatic cancer. This was mainly due to a prolonged metastasis-free interval following surgery.

Laryngeal preservation by treatment with induction chemotherapy and radiotherapy protocol for stage III & IV carcinoma larynx – results of a pilot study

1999 ◽  
Vol 113 (5) ◽  
pp. 433-438 ◽  
Author(s):  
A. Thakar ◽  
S. Bahadur ◽  
D. A. Tandon ◽  
A. Ranganathan ◽  
G. K. Rath
Keyword(s):  
Disease Free Survival ◽  
Stage Iii ◽  
Control Group ◽  
Free Survival ◽  
Carcinoma Larynx ◽  
Laryngeal Preservation ◽  
Group I ◽  
Initial Results ◽  
Disease Free ◽  
Surgical Salvage

AbstractTotal laryngectomy for advanced carcinoma of the larynx is effective but functionally disabling. In an effort at laryngeal preservation, 33 patients of stage III/IV carcinoma larynx were treated between 1987 and 1991 with induction chemotherapy followed by definitive radiation. Two chemotherapy protocols were administered. Group I patients received one to three cycles of cisplatin 100 mg/m2 (day 1), bleomycin 15 U/m2 (day 1), and 5-fluorouracil 1000 mg/m2/day (day 2 to 5) at three weekly intervals. This was then followed by radiotherapy. Group II received one to six weekly injections of single agent methotrexate 50 mg/m2 with or without leucocovorin rescue followed by radiotherapy. Any recurrence was salvaged by surgery.Midway through the study, Group II protocol was discontinued as the initial results were not comparable with Group I or standard treatment. The Group I protocol, however, yielded an initial locoregional control rate of 83.3 per cent With the addition of surgical salvage the locoregional control rate was 94.4 per cent and the control rate with laryngeal preservation was 88.8 per cent. The Kaplan-Meier probability of two years and five years disease-free survival was 81.9 per cent and 61.4 per cent respectively. For disease-free survival with laryngeal preservation the corresponding figures for two years and five years were 58.3 per cent and 41.7 per cent.The control group of 51 patients treated with radical surgery followed by radiotherapy yielded survival figures at two years and five years of 64.3 per cent and 57.2 per cent. The difference in the survival of Group I and the control group was not statistically significant (p value = 0.280). These initial results indicate that for stage III and for surgically resectable stage IV laryngeal carcinomas, a protocol of induction combination chemotherapy consisting of cisplatin, bleomycin and 5-fluorouracil followed by radiotherapy and combined with surgical salvage whenever required, can lead to comparable cure rates. In addition, a large proportion of patients are spared the morbidity of a total laryngectomy.

A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RARα transcript after consolidation therapy: The Japan Adult Leukemia Study Group (JALSG) APL97 study

Blood ◽  
2007 ◽  
Vol 110 (1) ◽  
pp. 59-66 ◽  
Author(s):  
Norio Asou ◽  
Yuji Kishimoto ◽  
Hitoshi Kiyoi ◽  
Masaya Okada ◽  
Yasukazu Kawai ◽  
...  
Keyword(s):  
Complete Remission ◽  
Acute Promyelocytic Leukemia ◽  
Randomized Study ◽  
Disease Free Survival ◽  
Promyelocytic Leukemia ◽  
Consolidation Therapy ◽  
Maintenance Chemotherapy ◽  
Free Survival ◽  
Significant Difference ◽  
Disease Free

To examine the efficacy of intensified maintenance chemotherapy, we conducted a prospective multicenter trial in adult patients with newly diagnosed acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy. Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission. Predicted 6-year overall survival in all assessable patients and disease-free survival in patients who achieved complete remission were 83.9% and 68.5%, respectively. A total of 175 patients negative for PML-RARα at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). Predicted 6-year disease-free survival was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the 2 groups (P = .20). Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = .014). These results indicate that the intensified maintenance chemotherapy did not improve disease-free survival, but rather conferred a significantly poorer chance of survival in acute promyelocytic leukemia patients who have become negative for the PML-RARα fusion transcript after 3 courses of intensive consolidation therapy.

Intensification of neoadjuvant therapy in patients with locally advanced rectal cancer

2021 ◽  
Vol 11 (2) ◽  
pp. 19-28
Author(s):  
Z. Z. Mamedli ◽  
A. V. Polynovskiy ◽  
D. V. Kuzmichev ◽  
S. I. Tkachev ◽  
A. A. Aniskin
Keyword(s):  
Rectal Cancer ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Control Group ◽  
Free Survival ◽  
Disease Free

The aim of the study: to increase the frequency of achieving pathologic complete response and increase disease-free survival in the investigational group of patients with locally advanced rectal cancer T3(MRF+)–4N0–2M0 by developing a new strategy for neoadjuvant therapy.Materials and methods. In total, 414 patients were assigned to treatment. Control group I included 89 patients who underwent radiotherapy (RT) 52–56 Gy/26–28 fractions with concurrent capecitabine twice daily 5 days per week. Control group II included 160 patients who underwent RT 52–56 Gy/26–28 fractions with concurrent capecitabine twice daily 5 days per week and oxaliplatin once a week, during the course of RT. Study group III consisted of 165 patients. This group combined RT 52–56 Gy/26–28 fractions with concurrent capecitabine twice daily 5 days per week and additional consecutive CapOx cycles. This group was divided into 2 subgroups: subgroup IIIa included 106 patients with consolidating chemotherapy (after CRT); subgroup IIIb included 59 patients who underwent “sandwich” treatment. Therapy consisted of conducting from 1 to 2 cycles of induction CapOx (up to CRT) and from 1 to 2 cycles of consolidating CapOx with an interval of 7 days. In the interval between the courses of drug therapy, RT 52–56 Gy/26–28 fractions was performed. According to the results of the control examination, further treatment tactics were determined. The primary end points were 5-year disease-free survival and the achievement of a pathologic complete response.Results. Pathologic complete response was significantly more often recorded in patients in the investigational group III (17.48 %; p = 0.021) compared with control groups (7.95 % in the I group and 8.28 % in the II group). 5-year disease-free survival in patients in the study groups was: 71.5 % in the III group, 65.6 % in the II group and 56.9 % in the I group.Conclusion. The shift in emphasis on strengthening the neoadjuvant effect on the tumor and improving approaches to drug therapy regimens have significantly improved disease-free survival of patients with locally advanced rectal cancer.

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.

1990 ◽  
Vol 8 (9) ◽  
pp. 1466-1475 ◽  
Author(s):  
N Wolmark ◽  
H Rockette ◽  
D L Wickerham ◽  
B Fisher ◽  
C Redmond ◽  
...  
Keyword(s):  
Portal Vein ◽  
Treatment Failure ◽  
Hepatic Metastases ◽  
Disease Free Survival ◽  
Treated Group ◽  
Control Group ◽  
Free Survival ◽  
National Surgical Adjuvant Breast ◽  
Bowel Project ◽  
Disease Free

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.

Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15.

1990 ◽  
Vol 8 (9) ◽  
pp. 1483-1496 ◽  
Author(s):  
B Fisher ◽  
A M Brown ◽  
N V Dimitrov ◽  
R Poisson ◽  
C Redmond ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Positive Node ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
National Surgical Adjuvant Breast ◽  
Significant Difference ◽  
Bowel Project ◽  
Disease Free

The National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented protocol B-15 to compare 2 months of Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) and cyclophosphamide (AC) with 6 months of conventional cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients with breast cancer nonresponsive to tamoxifen (TAM, T). A second aim was to determine whether AC followed in 6 months by intravenous (IV) CMF was more effective than AC without reinduction therapy. Through 3 years of follow-up, findings from 2,194 patients indicate no significant difference in disease-free survival (DFS, P = .5), distant disease-free survival (DDFS, P = .5) or survival (S, P = .8) among the three groups. Since the outcome from AC and CMF was almost identical, the issue arises concerning which regimen is more appropriate for the treatment of breast cancer patients. AC seems preferable since, following total mastectomy, AC was completed on day 63 versus day 154 for conventional CMF; patients visited health professionals three times as often for conventional CMF as for AC; women on AC received therapy on each of 4 days versus on each of 84 days for conventional CMF; and nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC. The difference in the amount of alopecia between the two treatment groups was less than anticipated. While alopecia was almost universally observed following AC therapy, 71% of the CMF patients also had hair loss and, in 41%, the loss was greater than 50%. This study and NSABP B-16, which evaluates the worth of AC therapy in TAM-responsive patients, indicate the merit of 2 months of AC therapy for all positive-node breast cancer patients.

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