Xeloda(Capecitabine)

Xeloda (Capecitabine) is approved for the adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. It is also indicated for the treatment of patients with advanced or metastatic breast cancer, either as a single agent if anthracycline- or taxane-containing chemotherapy is not indicated, or in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. Additionally, Xeloda is approved for the treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen, and for the treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. It is also indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. The drug received approval on December 14, 2022, under Application Number 020896Orig1s044,045,046,047,048,049,050,051.

In a single-arm, multicentre, open-label trial involving 35 patients (ITT population of 34) aged ≥3 and <18 years, the 1-year Progression-Free Survival (PFS) in the ITT population was 8%, compared to a historical control group of 15%. The 1-year Overall Survival (OS) in the ITT population was 42%, compared to a historical control group of 45.6%. One patient in the ITT population achieved a Partial Response, and 6 patients achieved Stable Disease, with 0 patients achieving Complete Response. The OS Hazard Ratio for XELOX vs FOLFOX-4 was 0.93. The PFS Hazard Ratio (IRC assessment, overall comparison) was 1.22, with a 97.5% CI of [1.05; 1.42].

Common adverse reactions include palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea (single agent, adjuvant colon cancer). For single-agent metastatic colorectal cancer, common adverse reactions include anemia, diarrhea, palmar-plantar erythrodysesthesia syndrome, hyperbilirubinemia, nausea, fatigue, and abdominal pain. When used with docetaxel for metastatic breast cancer, common adverse reactions include diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome, nausea, alopecia, vomiting, edema, and abdominal pain. Single-agent metastatic breast cancer treatment commonly resulted in lymphopenia, anemia, diarrhea, hand-and-foot syndrome, nausea, fatigue, vomiting, and dermatitis. In all patients, CNS necrosis occurred in 7%, vomiting in 80%, alanine aminotransferase increase in 75%, lymphocyte count decrease in 73%, white blood cell count decrease in 61%, and platelet count decrease in 57%.