scholarly journals The Evolving Strategy of Californium-252 Neutron Intracavitary Brachytherapy in Treating Patients With Low-Lying T2 or T3 Rectal Adenocarcinoma: From Fixed to Individualized Regime With Intrarectal Peritumoral Injection of Amifostine

2021 ◽  
Vol 11 ◽  
Author(s):  
Yanli Xiong ◽  
Li Shao ◽  
Jia Liu ◽  
Qian Zhou ◽  
Chongyi Li ◽  
...  
Keyword(s):  
Total Dose ◽  
External Beam Radiotherapy ◽  
Late Complication ◽  
Survival Rates ◽  
Rectal Adenocarcinoma ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Intracavitary Brachytherapy ◽  
Efficacy And Safety ◽  
Peritumoral Injection

PurposeTo retrospectively and comparatively evaluate the improvement of the efficacy and safety on the addition of 252Cf neutron intracavitary brachytherapy (ICBT), individualized or individualized with intrarectal peritumoral injection of amifostine (IPIA) to external-beam radiotherapy (EBRT) or concurrent chemo-EBRT in 314 patients with T2N0-1 or T3N0-1 low-lying rectal adenocarcinoma.MethodsPhase I: from 2009 to 2011, 157 patients were treated with additional 252Cf neutron ICBT for four fixed fractions with a total dose of 40–45 Gy-eq during the EBRT. Phase II: from 2011 to 2013, 75 patients were treated with individualized neutron ICBT delivered for two to five fractions with a total dose of 26–45 Gy-eq according to the response of tumor after concurrent chemo-EBRT. Phase III: from 2013 to 2014, 82 patients were treated with individualized ICBT protected by pretreatment IPIA.ResultsThe 4-year local control rates for the entire T2 and T3 patients were 69.4, 72.0, and 79.3%, while the 4-year overall survival rates were 63.1, 54.7, and 72.0% (P=0.08), and the 4-year disease-free survival rates were 55.4, 52.0, and 69.5% (P=0.053) in Phases I, II, and III, respectively. The late complication (LAC, ≥G2) rates were 33.8, 26.7, and 15.9%, respectively (P=0.012), and the serious LAC (≥G3) rates were 4.5, 4.2, and 0%, respectively, in Phases I, II, and III.ConclusionConcurrent chemo-EBRT combined with individualized 252Cf neutron ICBT protected by IPIA shows promising efficacy and safety in treating low-lying T2 and T3 rectal adenocarcinoma patients without surgery opportunity or willing.

scholarly journals The Combination of External Beam Radiotherapy with Cf (Californium)-252 Neutron Intracavitary Brachytherapy is Significantly Effective than with Ir (Iridium)-192 Gamma Intracavitary Brachytherapy in Controlling Stage IIB Cervical Adenocarcinoma: A Matched Pair Analysis

2020 ◽  
Author(s):  
Xin Lei ◽  
Yanli Xiong ◽  
Nan Gao ◽  
Chongyi Li ◽  
Shu Chen ◽  
...  
Keyword(s):  
Total Dose ◽  
Survival Data ◽  
External Beam Radiotherapy ◽  
Late Complication ◽  
Late Complications ◽  
Intracavitary Brachytherapy ◽  
Matched Pair ◽  
Complication Rates ◽  
External Beam ◽  
Matched Pair Analysis

Abstract Background: To assess the efficacy of combined external beam radiotherapy (EBRT) and intracavitary brachytherapy (ICBT) with Cf-252 neutrons versus Ir-192 photons in matched pairs for stage IIB adenocarcinoma of the uterine cervix (AC).Methods: Patients with stage IIB AC were matched into 19 pairs between January 2005 and March 2013 and were divided into neutron ICBT (NICBT) and photon ICBT (PICBT) groups. Pelvic EBRT was administered with 2 Gy/fraction, 4 fractions/week, to a total dose of 50–54 Gy, with the center of pelvic field blocked by 4 cm in width after 20–36 Gy in both groups. NICBT and PICBT were administered with 10.5–13 Gy-eq/fraction vs. 10–13 Gy/fraction, to a total dose of 42–53.2 Gy-eq vs. 40–51 Gy at point A. Radiotherapy was administered concurrently and sequentially with 2–4 cycles of chemotherapy, consisting of cisplatin, or carboplatin, and paclitaxel only in PICBT groups. Survival data and late complication rates were assessed using the Kaplan-Meier method, log rank, t test, and 2 × 2 contingency analysis. Results: The 5-year OS and DFS rate in the NICBT group were significantly higher than those of the PICBT group. Early treatment toxicity and late complications were mild in both groups. Conclusion: The combination of EBRT and Cf-252 neutron ICBT alone is more effective than the combination of EBRT and Ir-192 photon ICBT with concurrent and sequential chemotherapy for stage IIB AC patients.

Phase III Trial of Fluorouracil-Based Chemotherapy Regimens Plus Radiotherapy in Postoperative Adjuvant Rectal Cancer: GI INT 0144

2006 ◽  
Vol 24 (22) ◽  
pp. 3542-3547 ◽  
Author(s):  
Stephen R. Smalley ◽  
Jacqueline K. Benedetti ◽  
Stephen K. Williamson ◽  
John M. Robertson ◽  
Norman C. Estes ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Anterior Resection ◽  
Rectal Adenocarcinoma ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Adjuvant Chemoradiotherapy ◽  
Hematologic Toxicity ◽  
Free Survival ◽  
Locoregional Failure ◽  
Before And After

Purpose Adjuvant chemoradiotherapy after or before resection of high-risk rectal cancer improves overall survival (OS) and pelvic control. We studied three postoperative fluorouracil (FU) radiochemotherapy regimens. Patients and Methods After resection of T3-4, N0, M0 or T1-4, N1, 2M0 rectal adenocarcinoma, 1,917 patients were randomly assigned to arm 1, with bolus FU in two 5-day cycles every 28 days before and after radiotherapy (XRT) plus FU via protracted venous infusion (PVI) 225 mg/m2/d during XRT; arm 2 (PVI-only arm), with PVI 42 days before and 56 days after XRT + PVI; or arm 3 (bolus-only arm), with bolus FU + leucovorin (LV) in two 5-day cycles before and after XRT, plus bolus FU + LV (levamisole was administered each cycle before and after XRT). Patients were stratified by operation type, T and N stage, and time from surgery. Results Median follow-up was 5.7 years. Lethal toxicity was less than 1%, with grade 3 to 4 hematologic toxicity in 49% to 55% of the bolus arms versus 4% in the PVI arm. No disease-free survival (DFS) or OS difference was detected (3-year DFS, 67% to 69% and 3-year OS, 81% to 83% in all arms). Locoregional failure (LRF) at first relapse was 8% in arm 1, 4.6% in arm 2, and 7% in arm 3. LRF in T1-2, N1-2, and T3, N0-2 primaries who received low anterior resection (those most suitable for primary resection) was 5% in arm 1, 3% in arm 2, and 5% in arm 3. Conclusion All arms provide similar relapse-free survival and OS, with different toxicity profiles and central catheter requirements. LRF with postoperative therapy is low, justifying initial resection for T1-2, N0-2 and T3, and N0-2 anterior resection candidates.

Long-term results of Intergroup RTOG 91–11: A phase III trial to preserve the larynx—Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5517-5517 ◽  
Author(s):  
A. A. Forastiere ◽  
M. Maor ◽  
R. S. Weber ◽  
T. Pajak ◽  
B. Glisson ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Survival Rates ◽  
Disease Free Survival ◽  
High Volume ◽  
Phase Iii ◽  
Long Term Results ◽  
Free Survival ◽  
Significant Difference ◽  
Lower Death Rate

5517 Background: The 2-year results of Intergroup RTOG 91–11 were published in 2003 (NEJM 349:2091–8,2003). We now present the 5-year results (after median follow-up for surviving patients of 6.9 years) of 515 eligible pts with resectable stage III or IV (excluding T1 and high volume T4), cancer of the glottic or supraglottic larynx. Methods: Patients were randomized to induction cisplatin/5-FU (CF) with responders then receiving RT (I+RT) (n = 173); or concurrent cisplatin (100 mg/m2 q 21 days × 3) and RT (CRT) (n = 171); or RT alone (R) (n = 171). Laryngectomy was performed for < partial response to induction CF, for persistent/recurrent disease or for laryngeal dysfunction. Results: At 5 years, laryngectomy-free survival (LFS) was significantly better with either I+RT (44.6%, p = 0.011) or CRT (46.6%, p = 0.011) compared to R (33.9%). There was no difference in LFS between I+RT and CRT (p = 0.98). Laryngeal preservation (LP) was significantly better with CRT (83.6%) compared to I+RT (70.5%, p = 0.0029) or R (65.7%, p = 0.00017). Local-regional control (LRC) was significantly better with CRT (68.8%) compared to I+RT (54.9%, p = 0.0018) or R (51%, p = 0.0005). I+RT compared to R for LP and LRC showed no significant difference (p = 0.37 and 0.62, respectively). The distant metastatic rate was low (I+RT 14.3%, CRT 13.2%, R 22.3%) with a trend (p ∼0.06) for benefit from chemotherapy. Disease-free survival (DFS) was significantly better with either I+RT (38.6%, p = 0.016) or CRT (39%, p = 0.0058) compared to R (27.3%). Overall survival rates were similar for the first 5 years (I+RT 59.2%, CRT 54.6%, R 53.5%); thereafter I+RT had a non-significant lower death rate. Compared to CRT, significantly more pts in the R group died of their cancer (34% vs 58.3%, p = 0.0007); the rate for I+RT was 43.8%. Conclusion: These 5-year results differ from the 2-year analysis by a significant improvement in LFS now seen for both I+RT and CRT treatments compared to R. For the endpoints of LP and LRC, CRT is still the superior treatment with no advantage seen to the addition of induction CF to R. There is no significant difference in overall survival. [Table: see text]

A phase III protocol of androgen suppression (AS) and 3DCRT/IMRT versus AS and 3DCRT/IMRT followed by chemotherapy (CT) with docetaxel and prednisone for localized, high-risk prostate cancer (RTOG 0521).

2015 ◽  
Vol 33 (18_suppl) ◽  
pp. LBA5002-LBA5002 ◽  
Author(s):  
Howard M. Sandler ◽  
Chen Hu ◽  
Seth A. Rosenthal ◽  
Oliver Sartor ◽  
Leonard G. Gomella ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Type I ◽  
Current Standard ◽  
T Stage

LBA5002 Background: High-risk, localized prostate cancer (PCa) patients have a relatively poor prognosis. We hypothesized that the addition of adjuvant docetaxel and prednisone to long-term (24 month) AS and radiation therapy (RT) would improve overall survival (OS). Methods: RTOG 0521 opened December 2005 and closed August 2009 with targeted accrual of 600 cases. It was designed to detect improvement in 4-year OS from 86% to 93% with a 51% hazard reduction (HR = 0.49). Under a 0.05 1-sided type I error and 90% power, at least 78 deaths were required to analyze the OS endpoint. Patients had 1) Gleason (Gl) 7-8, any T-stage, and PSA > 20, or 2) Gl 8, ≥ T2, any PSA, or 3) Gl 9-10, any T-stage, any PSA. All had PSA ≤ 150. RT dose was 75.6 Gy. CT consisted of 6, 21-day cycles of docetaxel + prednisone starting 28 days after RT. Results: Of 612 enrolled, 50 were excluded for eligibility issues, leaving 562 evaluable. Median age = 66, median PSA = 15.1, 53% had Gl 9-10, 27% had cT3-4. Median follow-up = 5.5 yrs. 4-yr OS rates were 89% [95% CI: 84-92%] for the AS+RT arm and 93% [95% CI: 90-96%] for the AS+RT+CT arm (1-sided p = 0.03, HR = 0.68 [95% CI: 0.44, 1.03]). There were 52 centrally-reviewed deaths in the AS+RT arm and 36 in the AS+RT+CT arm, with fewer deaths both due to PCa/treatment (20 vs 16) and due to other causes/unknown (32 vs 20) in the AS+RT+CT arm. 5-yr disease-free survival rates were 66% for AS+RT and 73% for AS+RT+CT (2-sided p = 0.05, HR = 0.76 [95% CI: 0.57, 1.00]). There was 1, Gr 5 unlikely-related adverse event (AE) in the AS+RT arm and 2, Gr 5 possibly/probably-related AEs with AS+RT+CT. Conclusions: For high-risk, localized PCa, adjuvant CT improved the OS from 89% to 93% at 4 years. Toxicity was acceptable. This trial was designed with a short OS assessment period and additional follow-up is warranted to determine the long-term benefit of CT to the current standard of care of long-term AS+RT. This project was supported by grants U10CA21661, U10CA180868, U10CA180822, from the National Cancer Institute and Sanofi with additional support from AstraZeneca for Australian site participation. Clinical trial information: NCT00288080.

scholarly journals Comparison of Chemoradiotherapy and Radical Radiotherapy in Patients With Cervical Cancer

2020 ◽  
pp. 15-20
Author(s):  
Ozlem Yetmen Dogan ◽  
Ismet Sahinler
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Treatment Failure ◽  
Locally Advanced ◽  
Survival Rates ◽  
Disease Free Survival ◽  
High Response Rate ◽  
Intracavitary Brachytherapy ◽  
Radical Radiotherapy

Introduction: The current study aimed at comparing the results of radical radiotherapy (RT) or chemoradiotherapy (CRT) in patients with cervical cancer and evaluating the prognostic factors. Methods: CRT is the standard of care for locally advanced cervical cancer with the five-year survival rate of 30%–80%. In 1978-2006, a total of 716 patients with cervical cancer stage IB2-IVB were retrospectively analyzed for RT and CRT. In intracavitary brachytherapy, the median dose was 24 Gy and follow-up was 78 months. CRT was treated with 45 Gy external radiotherapy with cisplatin 40 mg/m2 given once a week. Results: The five-year pelvic control rate was 56.2% in the radical RT arm and 75.8% in the combined arm (P=0.01); disease-free survival and overall survival rates were 47%-56.3% (P=0.09) and 44.9%-52.5% (P=0.03), respectively. Treatment failure was detected in 317(50.5%) of 627 patients in the RT arm and in 30 (33.7%) of 89 patients in the CRT arm (Chi-squared value=8.86, P<0.01). Treatment failure rate was high in the 1st two years. Distant metastases were detected in 116 patients in the RT and 17 patients in the CRT arms. Hematological side effect rates in the CRT arm -anemia, thrombopenia, and leukopenia- were 33.7%, 13.5%, and 28.1%, respectively. The prevalence of rectitis, cystitis, and skin and subcutaneous fibrosis in the RT arm was 9.4%, 4.8%, and 2.2%, and in the CRT arm was 12.4%, 11.2%, and 13.5%, respectively. Conclusions: CRT increased pelvic control and overall survival rate based on the findings; it can be the preferred treatment modality because of its high response rate and acceptable toxicity.

The Four-Arm Cooperative Study (FACS) for advanced non-small cell lung cancer (NSCLC): A subgroup analysis in elderly patients (pts)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7115-7115
Author(s):  
K. Goto ◽  
Y. Nishiwaki ◽  
N. Saijo ◽  
K. Takeda ◽  
N. Katakami ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Survival Rates ◽  
Sensory Neuropathy ◽  
Patient Characteristics ◽  
Response Rates ◽  
The Elderly ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Platinum Based Chemotherapy ◽  
Grade 3

7115 Background: Efficacy and safety in fit, elderly NSCLC pts receiving platinum-based treatment have been reported to be similar to those in younger pts. However, there is controversy about which platinum-based regimens are suitable for the elderly. To compare efficacy and safety of platinum-based chemotherapy regimens in the elderly, we conducted an age specific subgroup analysis on FACS, a phase III randomized trial comparing four platinum-based regimens for advanced NSCLC. Methods: FACS was designed to compare three platinum-based combination regimens to cisplatin (80 mg/m2, day 1) plus irinotecan (60 mg/m2, days 1, 8, 15) (IP) as the reference arm. The experimental regimens were: carboplatin (AUC 6, day 1) plus paclitaxel (200 mg/m2, day 1) (TC); cisplatin (80 mg/m2, day 1) plus gemcitabine (1000 mg/m2, days 1, 8) (GP); cisplatin (80 mg/m2, day 1) plus vinorelbine (25 mg/m2, days 1,8) (NP). Results: Of the 105 pts ≥ 70 years (17% of 602 enrolled pts), 27 were on the IP arm, 27 on TC, 28 on GP, and 22 on NP. Patient characteristics were similar in each arm. Response rates were 26% in IP, 20% in TC, 32% in GP, 50% in NP. Frequency of grade 3 or greater leukocytopenia (IP/TC/GP/NP: 52%/33%/36%/86%) was higher in NP, and thrombocytopenia (IP/TC/GP/NP: 11%/19%/43%/0%) was higher in GP, however anemia (IP/TC/GP/NP: 56%/19%/29%/55%) was lower in TC and GP. Frequency of grade 2 or greater vomiting (IP/TC/GP/NP: 52%/22%/39%/41%) was lower in TC, and diarrhea (IP/TC/GP/NP: 48%/7%/4%/14%) was lower in TC, GP and NP, however, grade 2 or greater sensory neuropathy (IP/TC/GP/NP: 0%/22%/0%/0%) was higher in TC. One year survival rates were 48% for the IP arm, 48% for TC, 61% for GP, and 46% for NP. There were no significant survival differences between IP and each experimental regimen. In addition, no significant differences between ≥ 70 and < 70 years were observed in each treatment regimen regarding hematological and non-hematological toxicities, response rates, and survival, except that grade 3 or greater anemia was significantly higher in ≥ 70 years pts in IP and NP arms. Conclusions: These platinum-based four regimens were similarly active and tolerable for fit, elderly NSCLC pts, and their efficacy and toxicity in the elderly were similar to those in younger pts. No significant financial relationships to disclose.

Concurrent chemoradiotherapy with paclitaxel and cisplatin for adenocarcinoma of the cervix.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5086-5086
Author(s):  
Yutaka Nagai ◽  
Takafumi Toita ◽  
Morihiko Inamine ◽  
Wataru Kudaka ◽  
Tomoko Nakamoto ◽  
...  
Keyword(s):  
Survival Rate ◽  
Locoregional Recurrence ◽  
Concurrent Chemoradiotherapy ◽  
External Beam Radiotherapy ◽  
Disease Free Survival ◽  
Late Toxicity ◽  
Complete Response ◽  
High Dose Rate ◽  
Intracavitary Brachytherapy ◽  
High Dose

5086 Background: Adenocarcinoma of the cervix has a worse prognosis than its squamous counterpart, particularly when cancer cells spread beyond the uterine cervix. This is derived from the observation that adenocarcinoma is less sensitive to radiotherapy (RT) and chemotherapy It is unclear whether cisplatin-based concurrent chemoradiotherapy (CCRT) has the same effect on adenocarcinoma as on squamous cell carcinoma. Methods: We retrospectively analyzed 32 patients with stage IIB–IVA cervical adenocarcinoma who were treated with RT or CCRT. Fourteen patients were treated with RT from 1983–1996, 8 with CCRT using cisplatin alone (CCRT-P) from 1997–2002, and 10 with CCRT using cisplatin+paclitaxel (CCRT-TP) after 2003. The patients were treated with external beam radiotherapy, and low-dose or high-dose rate intracavitary brachytherapy. For CCRT-P, the patients received 20 mg/m2 cisplatin for 5 days every 3 weeks, and for CCRT-TP, the patients received 50 mg/m2 cisplatin every 3 weeks and 50 mg/ m2 paclitaxel weekly. Results: A complete response was achieved in 7/14 patients in the RT, 4/8 patients in the CCRT-P, and 9/10 patients in the CCRT-TP group. Ten of the 14 patients in the RT, 7/8 patients in the CCRT-P, and 2/10 patients in the CCRT-TP group experienced locoregional recurrence. The 5-year overall survival rate in the RT, CCRT-P, and CCRT-TP groups was 7.1%, 25.0%, and 74.1%, respectively (p = 0.0094), and their central disease-free survival rate was 21.4%, 12.5%, and 78.8%, respectively (p=0.0119). The acute toxicities associated with CCRT-TP are manageable. Regarding late toxicity of CCRT-TP, no grade 3/4 adverse effect was observed. Conclusions: The present study demonstrated that CCRT-TP achieved much better local control for adenocarcinoma of the cervix, leading to a decrease in locoregional recurrence. Prospective trials in larger series of patients are urgently needed.

Phase III Trial Comparing Doxorubicin Plus Cyclophosphamide With Docetaxel Plus Cyclophosphamide As Adjuvant Therapy for Operable Breast Cancer

2006 ◽  
Vol 24 (34) ◽  
pp. 5381-5387 ◽  
Author(s):  
Stephen E. Jones ◽  
Michael A. Savin ◽  
Frankie Ann Holmes ◽  
Joyce A. O'Shaughnessy ◽  
Joanne L. Blum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Standard Dose ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Surgical Excision ◽  
Phase Iii ◽  
Hormone Receptor Positive ◽  
Complete Surgical Excision

Purpose The combination of doxorubicin and cyclophosphamide (AC) is a standard adjuvant chemotherapy regimen. Studies of docetaxel and cyclophosphamide (TC) in metastatic breast cancer (MBC) showed promise in MBC. In 1997, we initiated a randomized adjuvant trial of TC compared with standard-dose AC with a primary end point of disease-free survival (DFS). Patients and Methods Patients were eligible if they had stage I to III operable invasive breast cancer with complete surgical excision of the primary tumor. Between June 1997 and December 1999, 1,016 patients were randomly assigned to four cycles of either standard-dose AC (60 and 600 mg/m2, respectively; n = 510) or TC (75 and 600 mg/m2, respectively; n = 506), administered intravenously every 3 weeks as adjuvant chemotherapy. Radiation therapy (as indicated) and tamoxifen, for patients with hormone receptor–positive disease, were administered after completion of chemotherapy. Results Both treatment groups (TC and AC) were well balanced with respect to major prognostic factors. Patients were observed through 2005 for a median of 5.5 years. At 5 years, DFS rate was significantly superior for TC compared with AC (86% v 80%, respectively; hazard ratio [HR] = 0.67; 95% CI, 0.50 to 0.94; P = .015). Overall survival rates for TC and AC were 90% and 87%, respectively (HR = 0.76; 95% CI, 0.52 to 1.1; P = .13). More myalgia, arthralgia, edema, and febrile neutropenia occurred on the TC arm; more nausea and vomiting occurred on the AC arm as well as one incident of congestive heart failure. Conclusion At 5 years, TC was associated with a superior DFS and a different toxicity profile compared with AC.

Randomized, Phase III Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin Alone in Postmenopausal Patients With Node-Positive Breast Cancer

2011 ◽  
Vol 29 (24) ◽  
pp. 3247-3254 ◽  
Author(s):  
R. Charles Coombes ◽  
Judith M. Bliss ◽  
Marc Espie ◽  
Frans Erdkamp ◽  
Jacob Wals ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Postmenopausal Women ◽  
Early Breast Cancer ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Node Positive

Purpose The Docetaxel Epirubicin Adjuvant (DEVA) trial evaluated the efficacy and toxicity of incorporating docetaxel after epirubicin to create a sequential anthracycline-taxane regimen in early breast cancer. Patients and Methods After complete tumor excision, postmenopausal women with node-positive early breast cancer were randomly assigned to either epirubicin 50 mg/m2 on days 1 and 8 every 4 weeks for six cycles (EPI × 6) or three cycles of epirubicin 50 mg/m2 on days 1 and 8 every 4 weeks followed by three cycles of docetaxel 100 mg/m2 on day 1 every 3 weeks (EPI-DOC). A subset of patients also participated in a quality of life (QOL) study. The primary end point was disease-free survival (DFS). Results From 1997 to 2005, 803 patients entered DEVA (EPI × 6, n = 397; EPI-DOC, n = 406). At a median follow-up of 64.7 months (interquartile range, 45.2 to 84.4 months), 198 DFS events had been reported (EPI × 6, n = 114; EPI-DOC, n = 84). The 5-year DFS rates were 72.7% (95% CI, 68.0% to 77.3%) for epirubicin alone and 79.5% (95% CI, 75.2% to 83.8%) for epirubicin followed by docetaxel; evidence of improvement in DFS was observed with EPI-DOC (hazard ratio [HR], 0.68; 95% CI, 0.52 to 0.91; P = .008). One hundred twenty-seven patients have died (EPI × 6, n = 75; EPI-DOC, n = 52); a reduction in deaths was observed with EPI-DOC (HR, 0.66; 95% CI, 0.46 to 0.94; P = .02). The 5-year overall survival rates were 81.8% (95% CI, 77.7% to 85.9%) for epirubicin and 88.9% (95% CI, 85.5% to 92.2%) for epirubicin followed by docetaxel. Assessment of toxicity and QOL showed that EPI-DOC was associated with greater toxicity but with no difference in QOL between arms during follow-up. Conclusion These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy.

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