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- Title
Metastatic and Adjuvant Colorectal Cancer Observational Study (MACRO Study).
- Authors
Ghosn, Marwan; El Karak, Fadi; Kattan, Joseph; Farhat, Fadi; Makdessy, Joseph; Chahine, Georges; Salem, Ziad; Awidi, Abdalla; Kourie, Hampig
- Abstract
Background: Colorectal cancer (CRC) is a highly prevalent major health problem constituting 10% of all diagnosed cancers and 9% of all cancer deaths. Systemic chemotherapy for colorectal cancer is recommended as a post-operative adjuvant therapy for patients with early stages of the disease and as 1st line metastatic chemotherapy for those with advanced stage. The traditional regimen in the past decades included 5FU/ LV. However, addition of Oxaliplatin to the 5-FU/LV regimen improved the clinical outcome in early and advanced stages of colorectal cancer. This study was conducted to assess the therapeutic management of Oxaliplatin/ 5-FU based regimen in both adjuvant and first line metastatic therapy in non-selected patients from Jordan and Lebanon with early and advanced stages of colorectal cancers. Methods: This was a multi-center, prospective, observational study that included patients with any stage of colorectal cancer whose physicians decided to treat with Oxaliplatin/ 5-FU based regimens as adjuvant or first line metastatic chemotherapy. All statistical tests were two-sided with a 5% significance level. Data was analyzed using SPSS (version 17). Adverse events were coded using MedDRA (version 18.0). Results: 563 patients were included in the trial and 513 were eligible for analysis. The demographics of the patients and the charac- teristics of the tumors were comparable between the adjuvant and metastatic chemotherapy groups. The median age of the patients was 61.9 years, 57.3% were male and only 2.8% had an ECOG ≥2. 98.4% of the tumors were adenocarcinoma and around 70% were moderately differentiated. 55% of the patients were treated with Oxaliplatin/ oral 5-FU regimen and 45% with Oxaliplatin/ 5-FU; no significant difference was found between the adjuvant and metastatic chemotherapy groups regarding the used regimens. The median number of treatment cycles administered by patients in the adjuvant chemotherapy group (9 cycles) was significantly higher (p=0.02) than that of the metastatic chemotherapy group (8 cycles), without affecting the median treatment duration that was around 5 months in both groups. The median dose intensities of Oxaliplatin and 5-FU in the adjuvant chemotherapy group were significantly higher than those in the metastatic group (p= 0.004 and p=0.001 respectively). 77.9% and 13.4% of patients receiving adjuvant chemotherapy presented respectively an adverse event or a serious adverse event in the adjuvant setting, while 74.7% and 29.6% in the metastatic setting. The incidence rate of serious adverse events was significantly higher among the metastatic group compared to the adjuvant group (x% vs. y%, p<0.001). The most frequently reported non-serious events were peripheral sensory neuropathy (50.3%), nausea (23.1%), diarrhea (20.6%), anemia (17.1%), vomiting (15.8%), thrombo- cytopenia (13.3%) and neutropenia (9.6%). The most frequently reported serious events (other than disease relapse/ recurrence/ pro- gression) were diarrhea (2.0%), vomiting (1.4%) abdominal pain (1.2%) and anemia (0.9%). Eight deaths were considered to be probably related to the chemotherapy treatment. Conclusions This trial revealed that oxaliplatin is administered at lower dose-intenstity and in fewer cycles in our studied population in Lebanon and Jordan. The incidence of peripheral neuropathy and other adverse events are lower in our population compared to those report- ed in the literature. Further prospective trials with long-term follow-up seem necessary to evaluate the impact of this clinical practice on the outcomes of the adjuvant and metastatic colorectal cancers.
- Subjects
LEBANON; JORDAN; COLORECTAL cancer; CANCER chemotherapy; ADJUVANT treatment of cancer; TUMOR classification; PHYSICIANS
- Publication
Pan Arab Journal of Oncology, 2019, Vol 12, Issue 1, p14
- ISSN
2070-254X
- Publication type
Article