Surgery of colorectal metastasis in the Optimox 1 study. A GERCOR Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3522-3522 ◽  
Author(s):  
N. Perez-Staub ◽  
G. Lledo ◽  
F. Paye ◽  
B. Gayet ◽  
M. Flesch ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Response Rate ◽  
Disease Free Survival ◽  
Complete Response ◽  
Additional Benefit ◽  
Curative Intent ◽  
Free Survival ◽  
Before And After ◽  
Unresectable Metastasis ◽  
Disease Free

3522 Background: Surgery of metastasis can cure arround 20% of metastatic colorectal cancer (MCRC) patients. The Optimox 1 study achieved a response rate over 50% with FOLFOX therapy in patients (pts) with initially unresectable metastasis which allowed to perform surgery in a significant number of pts (JCO 2006). We report here the results in pts who underwent surgery of metastasis (met). Methods: From jan 2000 to june 2002, 620 previously untreated patients with unresectable metastasis were randomized between FOLFOX4 every two weeks until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles and reintroduction of FOLFOX7 (arm B). 101 pts were resected with a curative intent, 57 in arm A and 45 in arm B. Results: Patients characteristics were (arm A/B %): metachronous metastasis 77/51, liver met 82/91, lung met 16/11, other met 7/4, PAL < 3 ULN: 98/97, normal LDH: 52/51. 8% of pts achieved a complete response, 72% a partial response, 16% a stable disease. 89 pts had a single resection, 12 had a two-stage surgery. One patient died in arm B. Eleven pts who relapsed had a second surgery. Resection was radical (R0) for 71 pts (43 in arm A and 28 in arm B), 15 were R1 (margin invasion) and 15 were R2. R0/R1 patients had a median overall survival (OS) of 51 mo in arm A and 38 mo in arm B. Median disease-free survival (DFS) since surgery was 12 mo in arm A and 9 mo in arm B, with no statistical difference. 32% of R0/R1 pts were alive with no progression at 3 years in arm A and 20% in arm B. Median time from randomization to surgery was 8 mo. No difference was found between patients resected before 8 mo (n = 50) and after (n = 37) in OS (39 vs 45 mo, p = .67) nor in DFS (11.6 vs 9.5 mo, p = .24). Neither in pts resected before and after 6 mo in OS (p = .77) and DFS (p = .44). Conclusions: FOLFOX treatment allowed 14 % of unresectable patients to be rescued by surgery. There was no additional benefit to perform surgery after 6 months of therapy compared to early surgery. [Table: see text]

The efficacy and feasibility of weekly 5-FU and cisplatin based radical concurrent chemoradiation therapy(CRT) in patients with esophageal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 169-169
Author(s):  
Joon Won Jeong ◽  
Ji Hyun Yang ◽  
Sang Mi Ro ◽  
In-Ho Kim ◽  
Sang Young Roh
Keyword(s):  
Esophageal Cancer ◽  
Median Overall Survival ◽  
Disease Free Survival ◽  
Squamous Carcinoma ◽  
Complete Response ◽  
Definitive Treatment ◽  
Free Survival ◽  
Promising Treatment ◽  
Grade 3 ◽  
Disease Free

169 Background: Concurrent chemoradiotherapy(CCRT) has become a promising treatment for esophageal cancer. Mostly, however, 3 week or 4 week interval of conventional FP(5-fluorouracil plus cisplatin) regimen is adopted, which is usually associated with moderate to severe treatment-related toxicities. Studies about weekly regimen of FP CCRT are little known, thus we studied the efficaty, tolerability and toxicities of weekly FP CCRT regimen. Methods: From February 2010 to august 2015, Patients staging from I to III esophageal cancer(according to AJCC 7th edition) were enrolled, who were received radiation therapy with dose of from 50.4Gy to 60Gy(5 days/week) and 5-FU 1000mg/BSA with cisplatin 30mg/BSA weekly. Results: From February 2010 to august 2015, 50 patients: male/female 47/3, median age 71.5 (47-78), all of 50 patients was squamous carcinoma, well/moderately differentiated carcinoma 1/18. 45 patients completed CRT without dose reduction, 9 patients received less than 6 cycles of chemotherapy, 4 patients received less than 50.4Gy of radiotherapy. Major toxicities of grade 3 or less were as follows: neutropenia 52%, thrombocytopenia 21%, nausea & vomiting 10%, fatigue 10%, anemia 5%. Toxicities over grade 4 was seen only in 1 patient. 15 patients showed complete response. The median overall survival was 10.67 months(4-48). The median disease-free survival was 16.9 months. Conclusions: Weekly regimen of concurrent CRT with 5-FU and cisplatin resulted in less toxicities over grade 3. Although, this regimen still showed non-inferiority to previous conventional 4 week-interval FP CCRT regimens in terms of PFS and OS. In this study, 82% of our patients had completed CCRT without any interruption. Hence, our results suggest that CRT with weekly 5-FU and cisplatin as definitive treatment for esophageal cancer could be a tolerable regimen.

Efficacy of HER2-targeted therapy for patients with HER2-positive breast cancer according to hormone receptor status.

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 97-97
Author(s):  
Takeshi Murata ◽  
Maiko Takahashi ◽  
Tetsu Hayashida ◽  
Hiromitsu Jinno ◽  
Yuko Kitagawa
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Hormone Receptor ◽  
Response Rate ◽  
Disease Free Survival ◽  
Complete Response ◽  
Her2 Positive ◽  
Free Survival ◽  
Significant Difference ◽  
Disease Free

97 Background: Hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive tumors generally cluster within the luminal/HER2 subset; whereas HR-negative/HER2-positive tumors reside in HER2-enriched subset. We investigated whether the efficacy of HER2-targeted therapy for HER2-positive tumors differs by HR status. Methods: Sixty-eight patients with operable breast cancer received trastuzumab plus taxane based therapy before surgery at Keio University Hospital from March 2009 to April 2012. All tumors were HER2-positive by immunohistochemistry (IHC) or fluorescence in situ hybridization. Expressions of ER, PgR, and Ki67 were performed by IHC in core needle biopsy samples at baseline. Pathological complete response (pCR) defined as no invasive residuals in breast. All patients with luminal/HER2 tumors received adjuvant endocrine therapy in addition to adjuvant trastuzumab monothereapy. Results: Sixty-eight patients with HER2-positive tumors were divided into 35 (51.5%) patients with luminal/HER2 tumors and 33(48.5%) patients with HER2-enriched tumors, respectively. There were no significant differences in tumor size, clinical nodal status, nuclear grade, and Ki67 status between the two groups. Clinical complete response rate and objective response rate were similar between the two groups. Patients with luminal/HER2 tumors were significantly younger than patients with HER2-enriched tumors (median age (range): 53 (35-78) vs. 61 (31-72), p=0.041). Compared to patients with luminal/HER2 tumors, patients with HER2-enriched tumors had significantly higher pCR rate (28.6% vs. 69.7%, p=0.002). With 24 months median follow-up, no significant differences were observed between the two groups with respect to disease-free survival. Estimated 2-year disease-free survival for luminal/HER2 and HER2-enriched was 94.3% and 97.0%, respectively (p=1.000). Conclusions: HER2-enriched breast cancer showed significantly higher pCR rate to HER2-targeted therapy compared with luminal/HER2 breast cancer. However, there was no significant difference in disease-free survival between the two groups.

Complete Response to Clofarabine Is Durable and Correlates with Survival in Previously Untreated Older Adult Patients with Acute Myeloid Leukemia (AML) and Unfavorable Prognostic Factors.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2061-2061 ◽  
Author(s):  
Janice Gabrilove ◽  
Stefan Faderl ◽  
Harry P Erba ◽  
David F. Claxton ◽  
M. Arellano ◽  
...  
Keyword(s):  
Overall Survival ◽  
Older Adult ◽  
Research Funding ◽  
Median Overall Survival ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Best Response ◽  
The Relationship ◽  
Disease Free

Abstract Abstract 2061 Poster Board II-38 Background: We have previously reported efficacy and safety of clofarabine in patients = 60 with at least one unfavorable prognostic factor. Retrospective analyses have suggested that survival in AML is related to quality of response. [Estey, Clinical Advances in Hematology Oncology, 2008]. In this report, we present durability and survival data for complete responders in each of the prognostic subgroups in the CLASSIC II trial, and a landmark analysis to evaluate the relationship between complete response and survival. Methods: This single arm, Phase II, open-label study enrolled adults with untreated AML =60 years old with at least one adverse prognostic factor: age =70 years, ECOG performance status (PS)=2; antecedent hematological disorder (AHD); and/or intermediate/unfavorable risk karyotype. Clofarabine was given on days 1-5 at 30 mg/m2 during induction and 20 mg/m2 during re-induction/consolidation. Primary endpoint was ORR (CR + CRp). Secondary efficacy endpoints included duration of remission (DoR), disease-free survival (DFS) and overall survival (OS). Due to interest about outcome of CR alone with respect to remission durability, such secondary endpoints were analysed and are reported below for the overall population and for each prospectively defined prognostic subgroup. Analyses of overall survival (OS) using both best response and landmark timepoints were performed. Landmark analyses eliminate survivorship bias by evaluating the robustness of the relationship between response and survival in patients who survived until a landmark timepoint and using the response at this timepoint for assessment rather than best response. Since this analysis was defined post hoc, 3 analyses of median overall survival in patients who survived at least 30, 45, and 60 days were performed to eliminate time-to-response bias. Results: 112 patients were evaluable. For patients with complete response (CR, n=42), median duration of remission (DoR) was 65 weeks (95% CI 41, not estimable [NE]), median disease free survival (DFS) 48 weeks (28, 65), and median overall survival (OS) 72 weeks (53, NE). Patients = 70 years (n=69) had 33% CR, median DoR and DFS 65 weeks (17, NE), and median OS = 48 weeks (48, NE). Patients with ECOG PS2 (n=25) had CR 24%, median DoR 7 weeks (6,NE), median DFS 9 weeks (6, 12), and median OS 16 weeks (12, 33). Patients with AHD (n= 41) had 39% CR; median DoR, DFS, and OS are NE. Patients with intermediate/unfavorable karyotype (n= 108) had 39% CR, median DoR 65 weeks (41, NE), median DFS 48 weeks (28, 65) and median OS 72 weeks (53, NE). Patients with unfavorable karyotype (n=62) had 32% CR, median DoR 56 weeks (28, NE), median DFS 33 weeks (23, 56), and median OS 59 weeks (48, NE). Median OS was 59.1 weeks (95% CI=49.9 weeks, NE) for CR + CRp; 33.4 weeks (95% CI=19.3, 55.0 weeks) for CRp; and15.4 weeks (95% CI=12.0, 29.9 weeks) for non-responders. In the landmark analysis, patients who had a complete response to clofarabine survived longer than non responders (Table 1), regardless of starting point (30, 45, or 60 days). The survival benefit of responders was statistically significant for all time points (p<0.05). Summary/conclusions: CRs were consistent, durable, and associated with survival of > 13 months in all prognostic subgroups except PS2, and complete responders lived longer than non-responders. Achievement of a CR correlates with clinical benefit and survival in older AML patients. Single agent clofarabine is an effective treatment option for older adult patients with untreated AML and unfavorable prognostic factors. Disclosures: Gabrilove: Genzyme: Research Funding. Faderl:Genzyme: Research Funding. Erba:Lilly: Research Funding; Antisoma: Research Funding; Wyeth: Research Funding; Cephalon: Honoraria, Research Funding; MGI Pharma: Honoraria; Pharmion: Honoraria; Celgene: Honoraria; BMS: Honoraria; Novartis: Honoraria, Research Funding; Genzyme: Consultancy, Honoraria, Research Funding; Gemin-X: Research Funding; Kanisa: Research Funding. Claxton:Genzyme: Research Funding. Arellano:Genzyme: Research Funding. Lyons:Celgene: Consultancy; Johnson&Johnson: Consultancy, Honoraria, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; Amgen Inc.: Consultancy, Honoraria, Research Funding, Speakers Bureau; Genzyme: Research Funding. Kovacsovics:Genzyme: Research Funding. Eckert:Genzyme: Employment. Huebner:Genzyme: Employment. Kantarjian:Genzyme: Research Funding.

Treatment of Indolent Lymphomas with 3 CNOP- 4 COPB.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4594-4594
Author(s):  
Edgar Murillo ◽  
Maria Nambo ◽  
Agustin Aviles ◽  
Natividad Neri ◽  
Alejandra Talavera ◽  
...  
Keyword(s):  
Response Rate ◽  
Chemotherapy Regimen ◽  
Disease Free Survival ◽  
Complete Response ◽  
Bulky Disease ◽  
Free Survival ◽  
Grade 3 ◽  
Indolent Lymphomas ◽  
Disease Free

Abstract Frequently recurrences and progressive resistance to chemotherapy characterize indolent lymphomas. The use of anthracyclines has been improved the response rate and the disease free survival, however, its use in elderly patients is controversial because the related toxicities. We analyze the use of a chemotherapy regimen with a short course of anthracycline. Material and Methods: We included patients with untreated indolent lymphomas according to the WHO classification. The chemotherapy regimens were 3 cycles of CNOP (cyclophosphamide 600 mg/m2 day 1, mitoxantrone 10 mg/m2 day1, vincristine 1.4 mg/m2 day 1 and prednisone 50 mg/m2 days 1–5) every 21 days, followed by 4 cycles of COPB (cyclophosphamide 800 mg/m2 day 1, vincristine 1.4 mg/m2 day 1, a bleomycin 10 U/m2 day 1 and prednisone 50 mg/m2 days 1–5) every 14 days. Results: In an intent to treat 75 patients were valuable, 37 females and 38 males, median age was 56 (range 28–84), the histological variants were: follicular grade 1 and 2 (45 patients), lymphoma/leukemia of small well differentiated lymphocytes (6 patients), mantle cell lymphoma (1 patient), nodal marginal zone lymphoma (4 patients), lymphoplasmocytic lymphoma (1 patient), indolent lymphoma not otherwise characterized (12 patients), 61 patients (81.3%) had bulky disease, 57 patients (76%) had advanced disease (stage III and IV). According to the IPI: low risk (28 patients), low intermediate (21 patients), high intermediate (14 patients), and high (12 patients). A total of 488 cycles were administrated, 82 (16.8%) cycles had hematologic toxicities: 30 cycles grade 1, 29 cycles grade 2, 18 cycles grade 3, and 5 cycles grade 4. Filgrastim was needed in 20 patients (43 cycles). 58 patients had gastrointestinal toxicity (29 grade1, 26 grade 2, 3 grade 3), 61 patients had neurological toxicity (47 grade 1, 13 grade 2, 1 grade 3). 14 patients (18.7%) required hospitalization, 7 patients due to toxicity related chemotherapy and 6 due to tumor progression. The overall response rate was 84% (63 patients): Complete response 33 patients (44%), unconfirmed complete response 6 patients (8%), partial response 24 patients (32%). Failure to treatment occurred in 11 patients (14.7%). Adding radiotherapy 12 more patients were converted to complete response for a total of 45 patients (60%). With a median of follow up of 24 months (range 3–62 months) 10 patients (13.3%) relapsed, 13 (17.3%) patients died (8 due to tumor progression and 3 related to toxicity of the regimen). The actuarial 5-year disease free survival was 71% and the overall survival 86%. Conclusions: This chemotherapy regimen provides an effective alternative for the treatment of indolent lymphomas even in advanced or bulky disease. This regimen is well tolerated for elderly patients and has a good safety profile. It is necessary a long time of follow up to establish the importance of the regimen in free disease survival and in overall survival.

scholarly journals Clinical features and outcomes of combined hepatocellular carcinoma and cholangiocarcinoma versus hepatocellular carcinoma versus cholangiocarcinoma after surgical resection: a propensity score matching analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chih-Wen Lin ◽  
Tsung-Chin Wu ◽  
Hung-Yu Lin ◽  
Chao-Ming Hung ◽  
Pei-Min Hsieh ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cancer ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Surgical Resection ◽  
Disease Free Survival ◽  
Clinicopathological Features ◽  
Free Survival ◽  
Before And After ◽  
Disease Free

Abstract Background Combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC) is an infrequent type of primary liver cancer that comprises hepatocellular carcinoma (HCC) and cholangiocarcinoma (CC). This study investigated the clinicopathological features and prognosis among cHCC-CC, HCC, and CC groups. Methods We prospectively collected the data of 608 patients who underwent surgical resection for liver cancer between 2011 and 2018 at E-Da Hospital, I-Shou University, Kaohsiung, Taiwan. Overall, 505 patients with cHCC-CC, HCC, and CC were included, and their clinicopathological features, overall survival (OS), and recurrence were recorded. OS and recurrence rates were analyzed using the Kaplan–Meier analysis. Results In the entire cohort, the median age was 61 years and 80% were men. Thirty-five (7.0%) had cHCC-CC, 419 (82.9%) had HCC, and 51 (10.1%) had CC. The clinicopathological features of the cHCC-CC group were more identical to those of the HCC group than the CC group. OS was significantly lower in the cHCC-CC group than in the HCC group but was not significantly higher in the cHCC-CC group than in the CC group. The median OS of cHCC-CC, HCC, and CC groups was 50.1 months [95% confidence interval (CI): 38.7–61.2], 62.3 months (CI: 42.1–72.9), and 36.2 months (CI: 15.4–56.5), respectively. Cumulative OS rates at 1, 3, and 5 years in cHCC-CC, HCC, and CC groups were 88.5%, 62.2%, and 44.0%; 91.2%, 76.1%, and 68.0%; and 72.0%, 48.1%, and 34.5%, respectively. After propensity score matching (PSM), OS in the cHCC-CC group was not significantly different from that in the HCC or CC group. However, OS was significantly higher in the HCC group than in the CC group before and after PSM. Furthermore, the disease-free survival was not significantly different among cHCC-CC, HCC, and CC groups before and after PSM. Conclusion The clinicopathological features of the cHCC-CC group were more identical to those of the HCC group than the CC group. The OS rate was significantly lower in the cHCC-CC group than the HCC group. However, after PSM, OS and disease-free survival in the cHCC-CC group were not significantly different from those in the HCC or CC group.

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.

scholarly journals Nodular mixed lymphoma: results of a randomized trial failing to confirm prolonged disease-free survival with COPP chemotherapy

Blood ◽  
1981 ◽  
Vol 58 (5) ◽  
pp. 920-925 ◽  
Author(s):  
JH Glick ◽  
JM Barnes ◽  
EZ Ezdinli ◽  
CW Berard ◽  
EL Orlow ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Eastern Cooperative Oncology Group ◽  
Disease Free Survival ◽  
Response Duration ◽  
Complete Response ◽  
Drug Regimen ◽  
Late Relapse ◽  
Hematologic Toxicity ◽  
Free Survival ◽  
Disease Free

Abstract Fifty-two patients with stage III or IV nodular mixed lymphocytic- histiocytic lymphoma (NM) were entered on a prospective randomized trial comparing cyclophosphamide-prednisone (CP) to either COPP (cyclophosphamide, vincristine, procarbazine, prednisone) or BCVP (BCNU, cyclophosphamide, vincristine, prednisone). The COPP regimen utilized in this Eastern Cooperative Oncology Group (ECOG) trial was similar to the four-drug regimen C-MOPP reported by the National Cancer Institute to achieve prolonged relapse-free survival in this histology. No significant differences in complete response rates, response duration, or overall survival were noted among the three regimens. A pattern of continuous late relapse was observed for all three chemotherapy programs. Although 11 of the 18 (61%) COPP patients achieved a complete response, only 3/11 (27%) remain disease-free with a median follow-up of over 3 yr. However, two of these three long-term complete responders have died with no clinical evidence of recurrent disease. The COPP patients received 84% of the calculated ideal doses of cyclophosphamide and 78% of the ideal dosage of procarbazine. Grade 3–4 hematologic toxicity was noted in 22% of the COPP group, 36% with BCVP, and 0% for the CP patients. We were unable to confirm the ability of COPP to achieve durable complete remissions in NM lymphoma. The cyclophosphamide-prednisone combination was equally effective when compared with COPP and BCVP, but produced minimal toxicity.

scholarly journals Stem Cells Inhibition by Bevacizumab in Combination with Neoadjuvant Chemotherapy for Breast Cancer

2019 ◽  
Vol 8 (5) ◽  
pp. 612 ◽  
Author(s):  
Renaud Sabatier ◽  
Emmanuelle Charafe-Jauffret ◽  
Jean-Yves Pierga ◽  
Hervé Curé ◽  
Eric Lambaudie ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Stem Cells ◽  
Tumor Cells ◽  
Disease Free Survival ◽  
Complete Response ◽  
Breast Cancer Patients ◽  
Open Label ◽  
Free Survival ◽  
Grade 3 ◽  
Disease Free

Preclinical works have suggested cytotoxic chemotherapies may increase the number of cancer stem cells (CSC) whereas angiogenesis inhibition may decrease CSC proliferation. We developed a proof of concept clinical trial to explore bevacizumab activity on breast CSC. Breast cancer patients requiring preoperative chemotherapy were included in this open-label, randomized, prospective, multicenter phase II trial. All received FEC-docetaxel combination, and patients randomized in the experimental arm received concomitant bevacizumab. The primary endpoint was to describe ALDH1 (Aldehyde dehydrogenase 1) positive tumor cells rate before treatment and after the fourth cycle. Secondary objectives included safety, pathological complete response (pCR) rate, disease-free survival (DFS), relapse-free survival (RFS), and overall survival (OS). Seventy-five patients were included. ALDH1+ cells rate increase was below the predefined 5% threshold in both arms for the 32 patients with two time points available. Grade 3 or 4 adverse events rates were similar in both arms. A non-significant increase in pCR was observed in the bevacizumab arm (42.6% vs. 18.2%, p = 0.06), but survival was not improved (OS: p = 0.89; DFS: p = 0.45; and RFS: p = 0.68). The increase of ALDH1+ tumor cells rate after bevacizumab-based chemotherapy was less than 5%. However, as similar results were observed with chemotherapy alone, bevacizumab impact on breast CSC cells cannot be confirmed.

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