Final results and subgroup analyses of the phase 3 CAIRO3 study: Maintenance treatment with capecitabine + bevacizumab versus observation after induction treatment with chemotherapy + bevacizumab in metastatic colorectal cancer (mCRC).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 3504-3504 ◽  
Author(s):  
Miriam Koopman ◽  
Lieke Simkens ◽  
Anne Maria May ◽  
Linda Mol ◽  
Harm van Tinteren ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Maintenance Treatment ◽  
Induction Treatment ◽  
Phase 3 ◽  
Subgroup Analyses

The JPJDF has Synergistic Effect with Fluoropyrimidine in the Maintenance Therapy for Metastatic Colorectal Cancer

2020 ◽  
Vol 15 (3) ◽  
pp. 257-269
Author(s):  
Xiaoling Fu ◽  
Yanbo Zhang ◽  
Lisheng Chang ◽  
Dengcheng Hui ◽  
Ru Jia ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Synergistic Effect ◽  
Maintenance Therapy ◽  
Metastatic Colorectal Cancer ◽  
Maintenance Treatment ◽  
Advanced Colorectal Cancer ◽  
Treated Group ◽  
Induction Treatment ◽  
Chemotherapeutic Regimen ◽  
Significant Difference

Background: Maintenance chemotherapeutic regimen with low toxicity is needed for metastatic colorectal cancer. A recent patent has been issued on the spleen-strengthening and detoxification prescription (JPJDF), a traditional Chinese herbal medicinal formula with anti-angiogenesis effect. The clinical effect of JPJDF on the maintenance treatment of advanced colorectal cancer has not been evaluated. Objective: This study aims to evaluate the effectiveness and safety of JPJDF in combination with fluoropyrimidine compared to fluoropyrimidine alone as maintenance therapy for metastatic colorectal cancer. Methods: We applied a prospective, randomized, double-blinded, single center clinical study design. A total of 137 patients with advanced colorectal cancer were recruited. Patients received either Fluoropyrimidine (Flu-treated group, n = 68), or Fluoropyrimidine plus JPJDF (Flu-F-treated group, n = 69) as maintenance treatment after 6-cycle of FOLFOX4 or FOLFORI induction treatment. The primary endpoints were Progression-Free Survival (PFS) and Overall Survival (OS). The secondary endpoints were safety, Performance Status (PS) score and other symptoms. Results: The endpoint of disease progression was observed in 91.7% of patients. The PFS was 5.0 months and 3.0 months in the Flu-F-treated and Flu-treated groups, respectively. The OS was 15.0 months and 9.0 months in the Flu-F-treated and Flu-treated groups, respectively. Some common symptoms, such as hypodynamia, anepithymia, dizziness and tinnitus and shortness of breath, were improved in the Flu-F-treated group. There was no significant difference in the common adverse reactions between the two groups. Conclusion: JPJDF and fluoropyrimidine have synergistic effect in the maintenance treatment of mCRC.

Intermittent maintenance treatment with bevacizumab in patients with metastatic colorectal cancer: A single centre experience.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 776-776
Author(s):  
Eleonora Cerchiaro ◽  
Michela Squadroni ◽  
Maria Grazia Sauta ◽  
Maria Bonomi ◽  
Federica Brena ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Maintenance Treatment ◽  
Small Sample Size ◽  
Small Sample ◽  
Induction Treatment ◽  
Group A ◽  
Grade 3 ◽  
Group B

776 Background: The main objective of care in patients with metastatic colorectal cancer (mCRC) is survival prolongation preserving the quality of life (QoL). Optimal duration of chemotherapy after induction treatment is still a matter of debate, such as the treatment strategies that could be adopted (intermittent versus continuous maintenance chemotherapy). Methods: In this monoinstitutional retrospective study we evaluated 70 patients (pts) diagnosed with mCRC with stable or responsive disease after chemotherapy with Bevacizumab (12 courses of FOLFIRI-Bevacizumab) as first or second-line treatment. We observed three groups: group A (20pts): maintenance therapy with de Gramont-Bevacizumab 2 months on/2 months off until disease progression (intermittent strategy); group B (30 pts): no maintenance treatment; group C (20 pts): induction treatment exclusively as first line followed by continuous maintenance with de Gramont-Bevacizumab. Results: Median progression free survival (PFS) was 21 months in Group A (range: 10-51 months), 9 months in Group B (range 6.6-12.9 months), 11 months in groups C (range 10.4-13.3 months), the difference resulted significant among group in favor of intermittent strategy (p = 0.006). Median OS was 60.6 months (range: 35.6-96.2 months) in group A, 27.2 months (range 19.5-39.9 months) in group B and 23.6 months in group C (range: 19.1-31 months); p = 0.0011. The most frequent adverse events of all grades were: hypertension, neutropenia, thrombocytopenia, diarrhea, asthenia. No toxic death was observed. Adverse events (AEs) of all grades were more frequent in group C (15% Grade 3-4), comparing with Group A and B (10% Grade 3-4 AEs) Conclusions: According to our retrospective analysis, intermittent maintenance treatment with chemotherapy and Bevacizumab appears to be a feasible strategy in pts with stable or responsive disease. PFS and OS resulted longer in patients treated with intermittent strategy comparing with other groups. The study has at least three bias: selection of patients, small sample size and retrospective nature, however we can conclude that intermittent strategy could improve patients outcome with an acceptable toxicity profile.

Comparative analysis of different maintenance regimens after first-line induction in patients with metastatic colorectal cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 789-789
Author(s):  
AMR Mohamed ◽  
Nadine Abdallah ◽  
Hibah Ismail ◽  
Wei Chen ◽  
Hyejeong Jang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Maintenance Treatment ◽  
Statistical Tests ◽  
Random Effect ◽  
Random Effect Model ◽  
Induction Treatment ◽  
P Value ◽  
First Line ◽  
Significant Difference

789 Background: Although, previous trials have demonstrated the benefits of maintenance chemotherapy for unresectable metastatic colorectal cancer (MCRC), the optimal maintenance regimen with acceptable safety profile is still undetermined. The primary objective of this meta-analysis was to compare the effectiveness of the most common clinically used maintenance regimens after first line therapy in MCRC. Methods: Among 52 prospective studies published 2009-2017, 14 were qualified for inclusion. Random-effect model was used for pooled effects within different categories include those with no maintenance treatment versus different maintenance regimens (Bevacizumab, capecitabine, bevacizumab plus capecitabine, bevacizumab plus erlotinib, and cetuximab). Primary endpoint was median progression free survival (PFS), and secondary endpoint was median overall survival (OS). All statistical tests were two-sided and p values < 0.05 were considered significant. Results: 14 studies with 3553 patients (57% males) were included in final analysis. Induction treatment was 5-FU or capecitabine - based chemotherapy with either oxaliplatin or irinotecan with or without bevacizumab. After stratifying for induction status, patients who did not receive treatment had worse PFS compared to maintenance treatment [pooled median PFS 3.52 months, 95% CI (2.97- 4.07) Vs 5.08 months, 95% CI (4.59- 5.57), z-test adjusted p-value 0.0005]. Among different maintenance regimens, capecitabine /bevacizumab combination showed better PFS [pooled median PFS 6.87 month, 95% CI (5.17- 8.57)], however the results were not significant (z test adjusted p-value 0.1383). No statistical significant difference in median OS between maintenance regimens. Conclusions: MCRC patients who did not receive maintenance treatment had shorter PFS. Although the superiority of bevacizumab plus capecitabine maintenance cannot be confirmed, there was a trend towards better PFS. This study suggests that bevacizumab plus capecitabine may be an appropriate maintenance option after first induction therapy depending on the tolerability and compliance with oral capecitabine.

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