Background
Anemia and iron deficiency are major concerns in cancer care, forming the first pillar of Patient Blood Management (PBM). In breast and gynecological cancers, anemia is common and adversely impacts prognosis by reducing chemotherapy tolerance, delaying treatment, and decreasing quality of life. Mechanisms include chronic inflammation, elevated hepcidin levels, impaired iron absorption, and ineffective erythropoiesis. While the 2013 Indian guidelines on anemia do not address oncology-specific management, the 2018 ESMO guidelines recommend intravenous (IV) iron for cancer patients with hemoglobin (Hb) less than 11 g/dL on chemotherapy. IV iron, particularly ferric carboxymaltose, is preferred over oral formulations due to faster correction, better tolerance, and ability to bypass hepcidin-mediated absorption block. At the study center, oncologists routinely administer IV iron with chemotherapy in anemic patients. Evidence suggests around 40 percent respond to IV iron within 3 weeks. However, its impact on transfusion dependence and quality of life in breast and ovarian cancer patients receiving neoadjuvant chemotherapy (NACT) remains unclear. Hypothesis
Null hypothesis (H0): IV iron therapy in anemic breast and ovarian cancer patients on NACT does not reduce transfusion rates, improve quality of life, or change patient-reported outcomes. Aim & Objectives Aim: To evaluate the efficacy of IV iron therapy in anemic breast and ovarian cancer patients planned for NACT. Primary Objective: To determine its effect on Hb levels. Secondary Objectives: Assess red cell transfusion rates. Evaluate fatigue, quality of life (FACT-An), and functional status (ECOG PS). Measure changes in patient-reported outcomes. Methodology
This is a prospective, observational, single-center, longitudinal cohort study at Mahamana Pandit Madan Mohan Malaviya Cancer Centre. Eligible patients: Hb less than 12 g/dL, diagnosed with breast or ovarian cancer, planned for NACT, and prescribed IV ferric carboxymaltose as standard care. After informed consent, baseline labs (Hb, hematocrit, serum iron, ferritin, TIBC, transferrin) will be recorded. QoL (FACT-An) and ECOG PS will be assessed. IV iron will be administered with chemotherapy at the day care center, and adverse events will be monitored. Exclusions: patients not receiving IV iron, allergic to iron therapy, or unable to continue treatment. Response will be assessed at 6 weeks: Responders: Hb increase more than or equal to 1 g/dL or Hb more than 11 g/dL. Non-responders: Hb increase less than 1 g/dL. PRBC transfusions will be given if Hb is less than 8 g/dL. Pre-surgical labs, QoL, and ECOG PS will be reassessed at surgery. Assessments: Baseline, 6 weeks, and 3 months. Sample Size
Based on detecting a 1 g/dL mean Hb difference (SD 4.1) with 90 percent power and Alpha equals 0.05, 200 patients are required. Accounting for approx. 10 percent attrition, 220 will be screened. Statistical Analysis Baseline characteristics: descriptive statistics. Normality: Kolmogorov–Smirnov test. Hb changes: paired t-test. Transfusion rates: Chi-square test. QoL: linear mixed models and paired t-test/Wilcoxon signed-rank test. ECOG PS: frequencies and percentages. Significance: p less than 0.05. Expected Impact
Findings will clarify the role of IV iron therapy in reducing transfusion needs, improving hemoglobin, and enhancing quality of life in anemic breast and ovarian cancer patients undergoing NACT. |