Eribulin Mesylate as Third or Subsequent Line Chemotherapy for Elderly Patients with Locally Recurrent or Metastatic Breast Cancer: A Multicentric Observational Study of GIOGer (Italian Group of Geriatric Oncology)-ERIBE.

BACKGROUND: Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. SUBJECTS, MATERIALS, AND METHODS: An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. RESULTS: Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend .018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10-10.33) and median OS was 7.31 months (3.70-14.03). The treatment was associated with mild toxicity. CONCLUSION: Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. IMPLICATIONS FOR PRACTICE: A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who are frequently elderly or frail. The assessment of geriatric parameters in the decision-making process can contribute to direct toward the most appropriate therapeutic plan and preserve the quality of life of patients. Eribulin does not seem to affect quality of life or worsen the overall geriatric status; therefore, it can be considered a suitable option for elderly patients with metastatic breast cancer.

Eribulin Treatment in Patients with Liver Metastatic Breast Cancer: Eight Italian Case Reports.

Liver metastases are very common in metastatic breast cancer (MBC); current treatments for these lesions are based on systemic chemotherapy, endocrine- or human epidermal growth factor receptor 2 (HER2)-targeted therapy, and palliative therapy. However, no standard approach has been clearly identified for second and further chemotherapy lines in MBC patients. In the phase III clinical trial EMBRACE, eribulin was particularly effective in reducing liver lesions and improving both overall survival and progression-free survival in liver MBC patients. In this series, we collected 8 case reports of Italian clinical practice in which eribulin has shown significant efficacy in reducing liver metastases in MBC patients: complete response was reported in 2 patients, and 4 patients achieved partial response. The treatment was well tolerated, thus confirming that eribulin is a suitable therapeutic option for elderly patients and for those who have metastatic HER2-negative disease. In the setting of MBC, the sequencing of therapeutic agents should consider expected response, side effects, tumor characteristics, and patient's preferences, in order to successfully tailor the most appropriate therapy beyond earlier lines.

Real-world ANASTASE study of atezolizumab+nab-paclitaxel as first-line treatment of PD-L1-positive metastatic triple-negative breast cancer.

The combination of atezolizumab and nab-paclitaxel is recommended in the EU as first-line treatment for PD-L1-positive metastatic triple-negative breast cancer (mTNBC), based on the results of phase III IMpassion130 trial. However, 'real-world' data on this combination are limited. The ANASTASE study (NCT05609903) collected data on atezolizumab plus nab-paclitaxel in PD-L1-positive mTNBC patients enrolled in the Italian Compassionate Use Program. A retrospective analysis was conducted in 29 Italian oncology centers among patients who completed at least one cycle of treatment. Data from 52 patients were gathered. Among them, 21.1% presented de novo stage IV; 78.8% previously received (neo)adjuvant treatment; 55.8% patients had only one site of metastasis; median number of treatment cycles was five (IQR: 3-8); objective response rate was 42.3% (95% CI: 28.9-55.7%). The median time-to-treatment discontinuation was 5 months (95% CI: 2.8-7.1); clinical benefit at 12 months was 45.8%. The median duration of response was 12.7 months (95% CI: 4.1-21.4). At a median follow-up of 20 months, the median progression-free survival was 6.3 months (95% CI: 3.9-8.7) and the median time to next treatment or death was 8.1 months (95% CI: 5.5-10.7). At 12 months and 24 months, the overall survival rates were 66.3% and 49.1%, respectively. The most common immune-related adverse events included rash (23.1%), hepatitis (11.5%), thyroiditis (11.5%) and pneumonia (9.6%). Within the ANASTASE study, patients with PD-L1-positive mTNBC treated with first-line atezolizumab plus nab-paclitaxel achieved PFS and ORR similar to those reported in the IMpassion130 study, with no unexpected adverse events.

PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting.

BACKGROUND: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients. METHODS: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS). RESULTS: Patients who received a first-line pertuzumab-based regimen showed better PFS (p < 0.0001) and OS (p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine (p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine (p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 (p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era. No significant differences emerged when comparing patients treated with 'old' or 'new' drugs (p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account. CONCLUSION: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited.

Incidence of invasive cervical cancer and direct costs associated with its management in Italy.

AIM AND BACKGROUND: Cervical cancer is the second most common cancer in European women aged 15-44 years. The aim of this study was to estimate the direct cost of managing invasive cervical cancer in Italy. METHODS: Data from the Italian Network of Cancer Registries were used to estimate the annual number of new cervical cancer cases. To assess the management costs, a typical management pathway for each FIGO (Fédération Internationale de Gynécologie et d'Obstétrique) cervical cancer stage was derived from published guidelines. Data from the Modena Cancer Registry were used to estimate the proportion of patients by FIGO stage. This algorithm was combined with tariffs for outpatient and inpatient procedures to obtain a mean cost for each FIGO stage. RESULTS: An estimated 2,927 new cases of cervical cancer occurred in Italy in 2005 (crude incidence 9.7/100,000; world age-standardized incidence 6.0/100,000). The estimated numbers of new cases by FIGO stage were: FIGO I, 1,927; FIGO II, 556; FIGO III, 259; and FIGO IV, 185. Costs for the most frequent procedures were estimated as: Euro 6,041 for radical hysterectomy or other surgery; Euro 4,901 for radio-chemotherapy; Euro 1,588 for brachytherapy; and Euro 3,795 for palliative chemotherapy. Mean management costs for incident cases (including 10 years of follow-up) were estimated at: FIGO I, Euro 6,024; FIGO II, Euro 10,572; FIGO III, Euro 11,367; FIGO IV, Euro 8707; and Euro 5,854 for the terminal phase (1 month). The total direct management cost was estimated at Euro 28.3 million per year. CONCLUSIONS: This is one of the first studies to estimate the direct cost of treating patients newly diagnosed with invasive cervical cancer in Italy. Although according to current management pathways real treatment costs are likely to be underestimated, this information is necessary to design evidence-based vaccination policies able to harmonize primary and secondary prevention of cervical cancer.

Communicating cancer diagnosis and prognosis: when the target is the elderly patient-a GIOGer study.

BACKGROUND: Effective communication to cancer patients allows better emotional response to diagnosis, coping with health professionals and compliance to treatment. We lack specific studies on patterns of clinical communication in elderly patients, their involvement in decision making and the role of their families. PATIENTS AND METHODS: Structured interviews to collect information on diagnosis and prognosis disclosure, satisfaction with information, compliance to disease experience and willingness toward receiving more information and coping, were administered to patients age 65 years and older and receiving chemotherapy. RESULTS: Six hundred and twenty two patients completed the interviews and were evaluated. Four hundred and twelve (66.2%) were informed, 210 (33.8%) were not informed. Information was associated with age, degree of education, geographical area, ECOG-PS, tumour site and family composition and the patient's perception of being supported in the disease experience. The majority of the patients consider their families as the main source of support in the disease experience (86.5%), wish to have a family member participating in oncology consultation (79.1%) and consider the information received complete and understandable or clear and reassuring (80%). Receiving adequate information facilitates a better patient-health professional relationship for 84.8% of the patients. 63% of the patients dealt positively with cancer and 62.2% showed positive expectations for the future. Informed patients refer better expectation than those not informed. CONCLUSION: Our study underlines the importance of clinical information for older cancer patients and the need to involve family members in the processes of diagnosis and prognosis disclosure and decision making. Health professionals must consider specific age-related issues including social, cultural and emotional aspects and understand the role that the family members play in the disease experience of elderly patients. Competent caring for elderly cancer patients must provide adequate information and emotional support not only to the patients but also to their family to assure appropriateness of care.