Survival Benefit with Standard-Dose Decitabine Versus Standard-Dose Azacitidine in Patients with Lower-Risk Myelodysplastic Syndromes

Abstract Introduction: Hypomethylating agents (HMAs) are used for the treatment of patients with myelodysplastic syndromes (MDS). Two HMAs, decitabine and azacitidine, are currently available for such treatment. Numerous studies have analyzed the clinical efficacy of HMAs in patients with MDS; however, reports directly comparing decitabine and azacitidine in patients with lower-risk (low and intermediate-1) MDS are limited. The clinical efficacy of standard-dose HMA treatment in lower-risk MDS remains controversial. Patients and methods: The Korea University MDS registry is a longitudinal cohort that contains data on 452 patients consecutively diagnosed with MDS from October 2006 to December 2017 in Korea University Medical Center (Korea University Anam, Guro, and Ansan Hospital). In the Korea University MDS registry, 357 patients were classified as having lower-risk MDS. Among them, 115 patients were treated with HMA (decitabine or azacitidine); 111 patients were eligible for the study. We compared treatment responses, survival outcomes, and adverse events between standard-dose decitabine (20 mg/m2 daily for 5 days every 4 weeks) and azacitidine (75 mg/m2 daily for 7 days every 4 weeks) in lower-risk MDS patients. Treatment responses were assessed according to the modified 2006 International Working Group response criteria. Patients who were evaluated received at least one cycle of HMA therapy. The overall response rate (ORR) included complete remission (CR), partial remission, marrow CR, and hematologic improvement. Progression-free survival (PFS) was measured from the time of treatment initiation until disease progression or death from MDS. Results: The CR rates were 16.4% (10/61) in the decitabine group and 6.0% (3/50) in the azacitidine group with borderline significance (P = .090). The ORRs were 67.2% (41/61) and 44.0% (22/50) for decitabine and azacitidine, respectively (P = .014). The erythroid responses for decitabine and azacitidine were 68.3% (41/60) and 44.2% (19/43), respectively (P = .014). In the multivariable analysis, treatment with decitabine (hazard ratio [HR] 2.553; 95% confidence interval [CI] 1.116-5.840; P = .026), hemoglobin (Hb) concentration of <8 g/dL (HR 3.073; 95% CI 1.340-7.048; P = .008), and ≥5% BM blasts (HR 3.739; 95% CI 1.102-12.683; P = .034) were significantly associated with higher ORRs. The median progression-free survival was significantly better in patients treated with decitabine than in those treated with azacitidine (33 vs. 19 months; P = .019). There were no significant differences in the event-free survival and in the overall survival between the two HMAs. In the multivariable analysis, treatment with decitabine (HR 0.496; 95% CI 0.257-0.957; P = .037) and achievement of CR (HR 0.122; 95% CI 0.015-0.993; P = .049) were significant prognostic factors for better survival, whereas ANC below 0.8 × 109/L (HR 1.905; 95% CI 1.032-3.515; P = .039) was a significant prognostic factor for poor prognosis. The poor cytogenetic risk group, as classified by International Prognostic Scoring System (HR 2.136; 95% CI 0.992-4.556; P = .052), also affected the survival unfavorably with borderline significance. There were no significant differences in grade 3 or higher hematologic adverse events between the two HMAs. Conclusions: The standard-dose decitabine therapy showed significantly better ORR, erythroid response, and longer PFS than did standard-dose azacitidine in patients with lower-risk MDS. The frequencies of hematologic adverse events did not differ between the patients who received decitabine and those who received azacitidine. Disclosures No relevant conflicts of interest to declare.

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Comparison between 5-day decitabine and 7-day azacitidine for lower-risk myelodysplastic syndromes with poor prognostic features: a retrospective multicentre cohort study

Scientific Reports ◽

10.1038/s41598-019-56642-1 ◽

2020 ◽

Vol 10 (1) ◽

Cited By ~ 1

Author(s):

Byung-Hyun Lee ◽

Ka-Won Kang ◽

Min Ji Jeon ◽

Eun Sang Yu ◽

Dae Sik Kim ◽

...

Keyword(s):

Adverse Events ◽

Myelodysplastic Syndromes ◽

Lower Risk ◽

Survival Rates ◽

Progression Free Survival ◽

Free Survival ◽

Prognostic Features ◽

Multicentre Cohort Study ◽

Treatment Responses ◽

Grade 3

AbstractNumerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). However, reports that compare the two HMAs, decitabine and azacitidine, in patients with lower-risk (low and intermediate-1) MDS are limited. We compared 5-day decitabine and 7-day azacitidine regimens in terms of treatment responses, survival outcomes, and adverse events in patients with lower-risk MDS with poor prognostic features. The overall response rates (ORRs) were 67.2% and 44.0% in the patients treated with decitabine and azacitidine, respectively (P = 0.014). While the median progression-free survival (PFS) was significantly better in the patients treated with decitabine than in those treated with azacitidine (P = 0.019), no significant differences in event-free and overall survival rates were observed between the two groups. Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs. In conclusion, in lower-risk MDS, especially with poor prognostic features, ORR and PFS were significantly better with 5-day decitabine treatment than with 7-day azacitidine treatment, with comparable safety.

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Cyclosporine Combined with Levamisole for Lower-Risk Myelodysplastic Syndromes

Acta Haematologica ◽

10.1159/000370097 ◽

2015 ◽

Vol 134 (3) ◽

pp. 138-145 ◽

Cited By ~ 6

Author(s):

Xingxin Li ◽

Jun Shi ◽

Min Wang ◽

Neng Nie ◽

Yingqi Shao ◽

...

Keyword(s):

Myelodysplastic Syndromes ◽

Lower Risk ◽

Response Rate ◽

Progression Free Survival ◽

The Novel ◽

Free Survival ◽

Immune Mediated ◽

Alternative Choice ◽

Median Interval

Clinical and experimental evidence suggests an immune-mediated pathophysiology in subjects with lower-risk myelodysplastic syndromes (MDS) in whom immunosuppressive therapy may be effective. The novel immunosuppressive strategy of cyclosporine A (CsA) alternately combined with levamisole (LMS; CsA + LMS regimen) can dramatically improve the response rate and survival in aplastic anemia from those of our previous study. Herein, we retrospectively analyzed the data of 89 lower-risk MDS patients who received the CsA + LMS regimen. A total of 63 patients (70.8%) achieved either complete remission or hematological improvement at 4 months. Overall, 51, 41 and 19 patients had erythroid, platelet and neutrophil responses, respectively. Following the CsA + LMS regimen, 6 patients progressed to more advanced MDS at a median interval of 5 months (range, 3-42 months). The estimated 24-month progression-free survival was 82.2% (95% CI, 72.84-91.56) for all patients. Within the median follow-up of 18.5 months (range, 7.0-61.0), 6 patients died. In conclusion, the CsA + LMS regimen alleviated cytopenias and improved survival and freedom from evolution, suggesting that it could be reserved as an alternative choice for lower-risk MDS.

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Impact of Red Blood Cell Transfusion Burden Status in Patients with Lower-Risk Myelodysplastic Syndromes

Blood ◽

10.1182/blood-2019-127486 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3013-3013

Author(s):

Montserrat Arnan Sangerman ◽

Helena Pomares ◽

Esther Alonso ◽

Javier Grau ◽

Mercedes Galiano ◽

...

Keyword(s):

Overall Survival ◽

Myelodysplastic Syndromes ◽

Lower Risk ◽

Progression Free Survival ◽

Low Risk ◽

Age At Diagnosis ◽

Free Survival ◽

The Impact ◽

Rbc Transfusion

Background: RBC-transfusion dependency (RBC-TD) is associated with a decreased probability of overall survival (OS) and progression free survival (PFS) in patients with myelodysplastic syndromes (MDS) (Malcovati L et al. J Clin Oncol 2007 25:3505) but it is unclear if transfusion dose burden is an independent prognostic factor. The purpose of this study was to assess the impact on lower-risk MDS patients, of RBC-transfusion (RBCT) burden status defined according to revised 2018 IWG criteria (Platzbecker et al; Blood 2018). Material and Methods: According to the R-IPSS selection criteria, we identified in our database 474 lower-risk (R-IPSS risk very low, low and intermediate) MDS patients diagnosed at the Catalan Institute of Oncology of Barcelona (01/1992-07/2018). Transfusion burden history was prospectively registered in our database. Data on the transfusion burden was calculated dividing the cumulative total of units of blood received at the end by the time since the beginning of the interval in which the first transfusion was received. RBCT burden, defined according to 2018 IWG criteria, divided patients into 3 categories (non-transfused [NTD], low transfusion burden [LTB] (3 to 7 units in 16 weeks) and high transfusion burden [HTB] patients (³ 8 units in 16 weeks). In this analysis, patients who had received 1 or 2 RBC units in 16 weeks, where included in the NTD category. Overall survival (OS) and progression free survival (PFS) were measured in years since diagnosis. Results: Median age at diagnosis was 72 years (range 32-101). 332 (70%) patients were male. WHO diagnosis was: 3% CRDU, 7% RA, 42% RCMD, 14% RAEB-1, 4% RAEB-2, 26% CMML, the remaining 4% were MDS-U and isolated 5q deletion. R-IPSS categories were: 178 (38%) very low risk, 219 (46.2%) low risk and 77 (16%) intermediate risk. Median follow up time for survivors was 5.4 years (range 0.25-23.8). 132 (28%) of patients were transfusion dependents (LTB and HTB patients). Mean dose density of packed red blood cells amongst those who were transfusion dependents was 3.2 units per month, with a median of 2.9 units per month (IQR 1.9-4.3). At the time of last follow up, 274 (58%) patients had died and 72 (15%) had progressed to AML. According to 2018 IWG criteria, RBCT burden categories were 342 (72%) NTD, 35 (7%) LTB and 97 (21%) HTB patients. Median OS for RBCT burden categories: NTD (8 years; 95% CI 6.6-9.5), LTB (6.2 years; 95% CI 4.2-8.1) and HTB (3.1 years; 95% CI 2.4-3.8) were significantly different (p<0.001; Figure 1). Moreover, the rate of progression to acute myeloid leukemia was 39 (11%), 7 (20%) and 26 (27%) for categories NTD, LTB and HTB respectively (p<0.001). Multivariate analysis performed included gender, age at diagnosis, IPSS-R and RBCT burden status and showed that RBCT burden status was associated with poor OS and PFS, independent of R-IPSS category, age and gender (Table 1). Transfusion burden was inversely associated with OS and PFS with an increasing effect on hazard ratio. Conclusions: Our results confirm in our single-centre experience the negative impact on survival and progression-free survival of RBCT treatment, even at relatively low dose burden. As therapeutical decisions are based on the initial prognostic risk assessment, the inclusion of RBCT burden categories may provide more precise prognostic information with impact on the therapeutic approach. Disclosures Sureda: Novartis: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria; Roche: Honoraria; BMS: Consultancy, Honoraria; Gilead: Consultancy; Janssen: Consultancy, Honoraria.

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Tolerability of ongoing phase II study of concomitant radiation and docetaxel followed by docetaxel in prostate cancer patients with a persistent or rising PSA after radical prostatectomy

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e16054 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e16054-e16054

Author(s):

A. M. Harris ◽

T. Y. Eng ◽

A. B. Karnad ◽

G. P. Swanson ◽

C. Jenkins ◽

...

Keyword(s):

Radical Prostatectomy ◽

Adverse Events ◽

Standard Dose ◽

Progression Free Survival ◽

Adjuvant Radiation ◽

Free Survival ◽

Secondary Endpoints ◽

Psa Progression ◽

Psa Nadir ◽

Grade 3

e16054 Background: Patients with a detectable PSA after radical prostatectomy (RRP) have persistent disease and inevitably succumb to disease as progression ensues. Radiation has been used in the salvage setting, but has only been found to cure less than half of these patients. SWOG 8794 has recently reported a significant increase in metastasis free survival in 15 years with adjuvant radiation for patients with high risk findings after RRP. It is of particular interest if adjuvant chemoradiation (CRT) can improve the rate of reaching a PSA nadir of zero after RRP in men with persistent or rising PSA. This ongoing IRB approved trial has thus far evaluated the tolerability of CRT utilizing the radiosensitizing agent Docetaxel (DX) for 7 weeks after RRP followed by adjuvant full dose DX (75mg/m2). Methods: Patients: Chemotherapy/hormone naïve, status post RRP, post-op PSA > 0.2 ng/mL on two separate occasions, ECOG ≤ 2; treated with taxane-based chemotherapy (DX 20mg/m2 weekly) concurrent with standard dose radiation for 7 weeks, and post-radiation chemotherapy DX (75mg/ m2) given every 21 days for 4 cycles with premedication intravenous dexamethasone. Primary endpoint: Rate of PSA decline; Number of subjects reaching PSA nadir of zero. Secondary endpoints: Progression Free Survival (PFS) based on PSA progression, toxicity graded via Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE), and overall survival (OS). Results: From 5/07 to 12/08, 16 pts with detectable PSA after RRP were treated; Median age 65 [48–74]; 16/16 completed CRT; 11/16 completed CRT and adjuvant DX; 3/16 dropped out due to adverse events after CRT; Toxicity: 19% (3/16) patients experienced Grade 3 toxicity during CRT and adjuvant DX; 29% (4/14) patients had Grade 3 toxicity during adjuvant DX; no Grade 4 toxicities. See Table . Conclusions: DX in combination with standard radiation appears to be well tolerated in patients with persistent PSA after RRP. [Table: see text] No significant financial relationships to disclose.

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Oncological outcome of patients with salivary gland cancer treated with surgery and postoperative intensity-modulated radiotherapy: a retrospective study

10.21203/rs.3.rs-33712/v1 ◽

2020 ◽

Author(s):

Shoumei Zang ◽

Meiqin Chen ◽

Huijie Huang ◽

Xinli Zhu ◽

Danfang Yan ◽

...

Keyword(s):

Salivary Gland ◽

Multivariable Analysis ◽

Intensity Modulated Radiotherapy ◽

Progression Free Survival ◽

Oncological Outcome ◽

Rank Test ◽

Salivary Gland Cancer ◽

Significant Prognostic Factor ◽

Free Survival ◽

Intensity Modulated

Abstract Background Salivary gland cancer (SGC) is comparatively rare and constitutes a variety of histological subtypes. Previously published studies included SGC patients who were irradiated using conventional radiotherapy or 3-dimensional conformal radiotherapy (3-DCRT) may have led to suboptimal oncological outcomes. Methods We identified 60 patients with major SGC treated with surgery followed by postoperative intensity-modulated radiotherapy (IMRT). Data for overall survival (OS), progression-free survival (PFS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), prognostic factors, and treatment-related toxicities were analyzed. Survival was analyzed using the Kaplan–Meier method and compared using the log-rank test. Results Adenoid cystic carcinoma (ACC) was the most common histology (n = 21; 35%). With a median follow-up of 55.5 months, OS and PFS were 90.7%, 85.1%, and 85.1%; and 80.1%, 72.7%, and 63.1%, at 3, 5, and 10 years, respectively. LRRFS and DMFS at 3, 5, and 10 years were 87.4%, 82.1%, and 82.1%; and 85.3%, 78.4%, and 66.1%, respectively. Five-year OS, PFS, LRRFS, and DMFS for ACC was 100%, 67.7%, 76.2%, and 90.2%, respectively. In multivariable analysis (MVA), N stage was an independent predictor of PFS (p = 0.047). Positive margin was a significant prognostic factor for PFS, LRRFS, and DMFS (p = 0.036, 0.026, and 0.011, respectively). Major nerve involvement was significantly correlated with PFS and DMFS (p = 0.034 and 0.008, respectively). Interval from surgery to radiotherapy (RT) predicted PFS and DMFS (p = 0.036 and 0.012, respectively). The most common acute toxicities were mucositis and dermatitis, and xerostomia was the most common late adverse event. Lung metastasis was the most common pattern of distant failure. Conclusion Postoperative IMRT leads to improved survival for SGC patients with acceptable toxicities.

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Oncological outcome of patients with salivary gland cancer treated with surgery and postoperative intensity-modulated radiotherapy: a retrospective study

10.21203/rs.3.rs-15982/v1 ◽

2020 ◽

Author(s):

Shoumei Zang ◽

Huijie Huang ◽

Xinli Zhu ◽

Meiqin Chen ◽

Danfang Yan ◽

...

Keyword(s):

Salivary Gland ◽

Prognostic Factors ◽

Multivariable Analysis ◽

Intensity Modulated Radiotherapy ◽

Progression Free Survival ◽

Oncological Outcome ◽

Salivary Gland Cancer ◽

Significant Prognostic Factor ◽

Free Survival ◽

Intensity Modulated

Abstract Background To investigate the outcomes, prognostic factors, patterns of failure, and adverse events in patients with salivary gland cancer (SGC) treated with surgery and postoperative intensity-modulated radiotherapy (IMRT). Methods We identified 60 patients with major SGC treated with surgery followed by postoperative IMRT. Data for overall survival (OS),progression-free survival (PFS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), prognostic factors, and treatment-related toxicities were analyzed. Survival was calculated with the Kaplan–Meier method. Multivariable analysis (MVA) was used to identify prognostic factors for OS, PFS, LRRFS and DMFS. Results Adenoid cystic carcinoma (ACC) was the most common histology ( n =21; 35%). With a median follow-up of 55.5 months, OS and PFS were 90.7%, 85.1%, and 85.1%; and 80.1%, 72.7%, and 63.1%, at 3, 5, and 10 years, respectively. LRRFS and DMFS at 3, 5, and 10 years were 87.4%, 82.1%, and 82.1%; and 85.3%, 78.4%, and 66.1%, respectively. Five-year OS, PFS, LRRFS, and DMFS for ACC was 100%, 67.7%, 76.2%, and 90.2%, respectively. In MVA, N stage was an independent predictor of PFS ( p =0.047). Positive margin was a significant prognostic factor for PFS, LRRFS, and DMFS ( p =0.036, 0.026, and 0.011, respectively). Major nerve involvement was significantly correlated with PFS and DMFS ( p =0.034 and 0.008, respectively). Interval from surgery to radiotherapy (RT) predicted PFS and DMFS ( p =0.036 and 0.012, respectively). The most common acute toxicities were mucositis and dermatitis, and xerostomia was the most common late adverse event. Lung metastasis was the most common pattern of distant failure. Conclusion Postoperative IMRT leads to improved survival for SGC patients with acceptable toxicities.

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Impact of red blood cell transfusion dose density on progression-free survival in patients with lower-risk myelodysplastic syndromes

Haematologica ◽

10.3324/haematol.2018.212217 ◽

2019 ◽

Vol 105 (3) ◽

pp. 632-639 ◽

Cited By ~ 4

Author(s):

Louise de Swart ◽

Simon Crouch ◽

Marlijn Hoeks ◽

Alex Smith ◽

Saskia Langemeijer ◽

...

Keyword(s):

Blood Cell ◽

Red Blood Cell ◽

Myelodysplastic Syndromes ◽

Lower Risk ◽

Progression Free Survival ◽

Red Blood Cell Transfusion ◽

Free Survival

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Addition of Camrelizumab to Transarterial Chemoembolization in Hepatocellular Carcinoma With Untreatable Progression

10.21203/rs.3.rs-771504/v1 ◽

2021 ◽

Author(s):

Yanqiao Ren ◽

Ziyi Liu ◽

Joyman Makamure ◽

Xuefeng Kan ◽

Songlin Song ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Adverse Events ◽

Transarterial Chemoembolization ◽

Objective Response ◽

Multivariable Analysis ◽

Progression Free Survival ◽

Free Survival ◽

Endothelial Proliferation ◽

Tace Group ◽

Tace Treatment

Abstract Purpose: To evaluate the efficacy and safety of camrelizumab addition to transarterial chemoembolization (TACE) in treatment of hepatocellular carcinoma (HCC) with TACE-related untreatable progression (UP).Methods: Patients with HCC who received addition of camrelizumab due to UP after initial TACE treatment were enrolled at our institution between May 2019 and January 2021. Patients were assessed for tumor response, progression-free survival (PFS), and adverse events. Risk factors for PFS were evaluated with logistic regression analysis.Results: A total of 41 patients were included. The objective response rate and disease control rate were 24.4% and 61.0% at 2-3 months, and 12.2% and 58.5% at 6 months, respectively. The median PFS of the patients were 6 months (95% CI: 3.8 months, 8.2 months). Of the 41 patients, 23 patients received camrelizumab combined with TACE (hereafter, camrelizumab-TACE), in whom 52 combined TACE procedures were performed, with a median of 2 procedures (range, 1-6) per patient. The remaining 18 patients received camrelizumab alone due to TACE contraindications. Multivariable analysis indicated that camrelizumab-TACE was an independent prognostic factor for PFS. Subgroup analysis showed a median PFS of 8 months in the camrelizumab-TACE group and 3 months in the camrelizumab monotherapy group (P<0.001). No treatment-related mortalities occurred. Seventeen patients (41.5%) developed at least one type of adverse events after treatment with camrelizumab, with reactive cutaneous capillary endothelial proliferation (n=14, 34.1%) being the most common adverse events.Conclusions: Addition of camrelizumab to TACE offered an effective and safe treatment for HCC with UP.

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Efficacy of lenvatinib for unresectable hepatocellular carcinoma based on background liver disease etiology: multi-center retrospective study

Scientific Reports ◽

10.1038/s41598-021-96089-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Atsushi Hiraoka ◽

Takashi Kumada ◽

Toshifumi Tada ◽

Joji Tani ◽

Kazuya Kariyama ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Prognostic Factors ◽

Liver Disease ◽

Hazard Analysis ◽

Progression Free Survival ◽

Significant Prognostic Factor ◽

Disease Etiology ◽

Alcoholic Fatty Liver ◽

Free Survival ◽

Significant Difference

AbstractIt was recently reported that hepatocellular carcinoma (HCC) patients with non-alcoholic steatohepatitis (NASH) are not responsive to immune-checkpoint inhibitor (ICI) treatment. The present study aimed to evaluate the therapeutic efficacy of lenvatinib in patients with non-alcoholic fatty liver disease (NAFLD)/NASH-related unresectable-HCC (u-HCC). Five hundred thirty u-HCC patients with Child–Pugh A were enrolled, and divided into the NAFLD/NASH (n = 103) and Viral/Alcohol (n = 427) groups. Clinical features were compared in a retrospective manner. Progression-free survival (PFS) was better in the NAFLD/NASH than the Viral/Alcohol group (median 9.3 vs. 7.5 months, P = 0.012), while there was no significant difference in overall survival (OS) (20.5 vs. 16.9 months, P = 0.057). In Cox-hazard analysis of prognostic factors for PFS, elevated ALT (≥ 30 U/L) (HR 1.247, P = 0.029), modified ALBI grade 2b (HR 1.236, P = 0.047), elevated AFP (≥ 400 ng/mL) (HR 1.294, P = 0.014), and NAFLD/NASH etiology (HR 0.763, P = 0.036) were significant prognostic factors. NAFLD/NASH etiology was not a significant prognostic factor in Cox-hazard analysis for OS (HR0.758, P = 0.092), whereas AFP (≥ 400 ng/mL) (HR 1.402, P = 0.009), BCLC C stage (HR 1.297, P = 0.035), later line use (HR 0.737, P = 0.014), and modified ALBI grade 2b (HR 1.875, P < 0.001) were significant. Lenvatinib can improve the prognosis of patients affected by u-HCC irrespective of HCC etiology or its line of treatment.

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Bevacizumab plus capecitabine as later-line treatment for patients with metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines

Scientific Reports ◽

10.1038/s41598-021-86482-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yeong Hak Bang ◽

Jeong Eun Kim ◽

Ji Sung Lee ◽

Sun Young Kim ◽

Kyu-Pyo Kim ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Median Overall Survival ◽

Treatment Options ◽

Multivariable Analysis ◽

Progression Free Survival ◽

Line Treatment ◽

Free Survival ◽

Medical Need ◽

Significant Disease

AbstractThere is an unmet medical need for later-line treatment options for patients with metastatic colorectal cancer (mCRC). Considering that, beyond progression, co-treatment with bevacizumab and cytotoxic chemotherapy showed less toxicity and a significant disease control rate, we aimed to evaluate the efficacy of capecitabine and bevacizumab. This single-center retrospective study included 157 patients between May 2011 and February 2018, who received bevacizumab plus capecitabine as later-line chemotherapy after progressing with irinotecan, oxaliplatin, and fluoropyrimidines. The study treatment consisted of bevacizumab 7.5 mg/kg on day 1 and capecitabine 1,250 mg/m2 orally (PO) twice daily on day 1 to 14, repeated every 3 weeks. The primary endpoint was progression-free survival (PFS). The median PFS was 4.6 months (95% confidence interval [CI] 3.9–5.3). The median overall survival (OS) was 9.7 months (95% CI 8.3–11.1). The overall response rate was 14% (22/157). Patients who had not received prior targeted agents showed better survival outcomes in the multivariable analysis of OS (hazard ratio [HR] = 0.59, 95% CI 0.43–0.82, P = 0.002) and PFS (HR = 0.61, 95% CI 0.43–0.85, P = 0.004). Bevacizumab plus capecitabine could be a considerably efficacious option for patients with mCRC refractory to prior standard treatments.

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