Volume 24, Issue 105, September - October, 2020

Comparative study of metronomic capecitabine and oxaliplatin versus classic XELOX in Egyptian metastatic colorectal cancer patients

Raghda Y. Abu El-Ela^1♦, Mostafa M. El-Serafy², Maha Yahia², Mervat M. Omran⁴, Rasha Allam³, Samia A. Shouman⁴

¹Clinical Oncology Department, Faculty of Medicine, Fayoum University, Egypt
²Medical Oncology Department, National Cancer Institute, Cairo University, Egypt
³Department of Medical Statistics, National Cancer Institute, Cairo, Egypt
⁴Pharmacology, Unit, Cancer Biology Department, National Cancer Institute, Cairo University, Egypt

^♦Corresponding author
Clinical Oncology Department, Faculty of Medicine, Fayoum University, Egypt; Email: raghda_yahia@yahoo.com / raghdayahia12@gmail.com

ABSTRACT

Background: In Egypt, colorectal cancer (CRC) is a diagnosis of advanced tumors. While the drastic survival gains with standard doses of chemotherapy have significant toxicity in certain CRC patients. Less than the maximum tolerated dose of chemotherapy, with no prolonged drug-free breaks, tumor progression is impeded. Therefore, a safer alternative to standard dose therapy with a safer toxicity profile would be. Methods: This is a Phase II randomized study which included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute of Egypt. Patients were treated with either classic XELOX (arm A) or capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg / m2 weekly X 8 weeks) followed by 2 weeks of rest (arm B). Both therapies continued until the disease progressed or were tolerated. Toxicity and analysis of survival were recorded after two years. Results: The mean PFS was 7.6 months for patients receiving Arm A, while patients receiving the arm B was 5.7 months (P=0.318). Median OS for arms A & B were nearly equal (15.9 m &15.8m) (P = 0.8). Disease control rate was slightly higher in arm A (48%) than arm B (37%) (P=0.3). Most toxicity was higher in group A (P-values: anemia 0.03, diarrhea 0.027, hand & foot syndrome 0.002, neutropenia 0.001, oral mucositis 0.003, and gastritis 0.004). Also, higher grade III toxicities in arm A; anemia, hand and foot syndrome, diarrhea, fatigue, gastritis (P-values: 0.017, <0.001, 0.009, <0.001, <0.0001) respectively. Conclusion: Metronomic protocol had significantly lower rates of most toxicities and grade III ones than standard protocol with equal OS, the use of metronomic treatment did not affect PFS or response rates.

Keywords: colorectal cancer, metronomic, capecitabine, XELOX, Egyptian patients

Medical Science, 2020, 24(105), 3041-3050

PDF