An evaluation of the Index4 tool for chemotherapy toxicity prediction in cancer patients older than 70 years old.

Chemotherapy, although beneficial for improving outcomes in both localized and metastatic cancers, may be associated with significant adverse effects, especially for patients with decreased functional reserves. Prediction of patients who will not tolerate well chemotherapy treatment may help in modifying treatment plans and in reallocating resources to vulnerable patients. One hundred seventeen consecutive cancer patients over the age of 70 scheduled for chemotherapy treatment in a single cancer center were included in the study. Prediction of adverse chemotherapy outcomes were calculated using a prediction tool proposed and validated from the Cancer and Aging Research Group (CARG) and a prediction tool proposed by us, called Index4. The 2 tools were compared for their ability to predict grade 3 and 4 toxicities, Emergency Department (ED) and hospital admissions and chemotherapy discontinuation. The accuracy of both predictive tools was suboptimal. A high CARG score had a sensitivity of 46.3% and a specificity of 82% and an Index4 of 1 or above had a sensitivity of 53.7% and a specificity of 60% in predicting grade 3-4 adverse effects. The performance of the 2 tools in predicting ED and hospital admissions and chemotherapy discontinuation was comparable. An Index4 score of 0 was superior in predicting absence of grade 3-4 toxicities than a low CARG score (p = 0.002, McNemar's test). The CARG tool for chemotherapy adverse effect prediction in geriatric cancer patients and the Index4 were able to predict adverse outcomes with moderate accuracy. Given its ease of calculation Index4 may be an alternative to CARG tool, suitable for a busy oncology practice.

Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial.

PURPOSE: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD. METHODS: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes. RESULTS: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores (P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1). CONCLUSION: MF significantly reduces RD in patients undergoing breast radiotherapy.

Prognostic Role of Tumor Budding in Breast Cancer Patients Receiving Neo-Adjuvant Therapy.

BACKGROUND: Isolated tumor cells or small clusters of tumor cells observed in the vicinity of the main tumor mass in pathology sections, termed tumor budding, are common in cancers and have been associated with prognosis in some settings. This study examined the clinical associations and treatment efficacy implications of tumor budding in breast cancer patients receiving neo-adjuvant therapy. METHODS: Breast cancer patients that received neo-adjuvant therapy before definitive surgical treatment in a single cancer center over a 7-year period were included, and their records were reviewed. Data extracted included patient demographics, tumor characteristics and pathologic response to treatment at surgery. The initial breast cancer biopsy before any therapy was reviewed by two pathologists, and a hot spot area was evaluated for tumor budding (defined as 1 to 5 cancer cells observed detached from the main tumor mass). RESULTS: Seventy-five patients who received neo-adjuvant therapy (73 received chemotherapy and 2 received hormonal therapy) were included. Tumor budding was observed in two-thirds of the patients. There were no significant differences in patient (age and menopause status) and tumor (stage, histology and molecular sub-type equivalent) characteristics between the group that had tumor budding and the group that did not have tumor budding in the pre-treatment biopsy. Likewise, no statistically significant differences were observed in the frequency of complete or partial responses between the two groups. CONCLUSION: In this cohort of breast cancer patients receiving neo-adjuvant therapy, tumor budding was frequent, but it was not associated with tumor characteristics or pathologic responses to treatment. The value of tumor budding as a prognostic factor in the neo-adjuvant setting within the general breast cancer population could not be confirmed, but such a value in specific sub-groups deserves further investigation, given the pathophysiologic rationale and data from other settings.

Prediction of hospital admissions and grade 3-4 toxicities in cancer patients 70 years old and older receiving chemotherapy.

AIM: To predict chemotherapy toxicity and hospitalisations in elderly patients using clinical and laboratory parameters. METHODS: Records of cancer patients 70 years old or older who received adjuvant chemotherapy or first-line chemotherapy for a cancer in a single centre were reviewed. Factors associated with hospitalisations, grade 3-4 toxicities and dose reductions during treatment were evaluated. RESULTS: A total of 275 patients included in the study. Most patients (53.8%) were 70 to 75 years old. One hundred and five patients (38.2%) had a hospital admission during or within a month after their chemotherapy treatment. The only factor associated with admissions in the multivariate analysis was ECOG performance status (PS) >1 (p = .008, odds ratio 2.66, 95% CI: 1.28-5.53) and hypoalbuminaemia approached significance. Grade 3 and 4 toxicities were associated with a lower creatinine clearance in the multivariate analysis (p = .01, odds ratio 0.98, 95% CI: 0.97-1.0), and dose reductions were associated with metastatic stage (p = .03, odds ratio 1.88, 95% CI: 1.05-3.35). A combined index with all four parameters was associated with all three outcomes of interest. CONCLUSION: ECOG PS, stage, albumin and creatinine clearance may be predictive of hospital admissions, grade 3-4 toxicities and dose reduction rates in cancer patients 70 years old and older receiving chemotherapy.

The metabolic syndrome and its components as prognostic factors in metastatic colorectal cancer.

BACKGROUND: Components of the metabolic syndrome (MetS) are involved in colorectal cancer development and the incidence of the disease is higher in obese and diabetic patients. Nevertheless, the value of these diseases or the MetS as a whole as prognostic markers once colorectal cancer is diagnosed is controversial. METHODS: Patients with metastatic colorectal cancer treated in our center over a 6-year period were reviewed and data on baseline characteristics of the patients and their cancers were extracted. Data on the presence and pharmacologic treatments of the four components of the MetS (obesity, diabetes, hypertension, and dyslipidemia) were also recorded. Overall survival (OS) and progression-free survival (PFS), Kaplan-Meier curves of the various groups were constructed and compared with the log-rank test. RESULTS: One hundred and twenty-three patients were included in the analysis. The prevalence of the four MetS components was 66.1% for overweight/obesity, 25.2% for diabetes, 61% for hypertension, and 41.5% for dyslipidemia. Among the four components of the metabolic syndrome, none was associated with either PFS or OS. Diabetes tended to approach significance for PFS (p = 0.08). The MetS as a whole did not influence survival outcome. MetS was not prognostic even if the overweight category was not considered as a positive element of the syndrome. CONCLUSION: These data suggest that diabetes or other metabolic syndrome elements are not prognostic factors for PFS or OS in metastatic colorectal cancer. Further investigation may be warranted with a focus on refinement of the metabolic evaluation.