Purpose Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting. Patients and Methods Patients who had received no more than one previous chemotherapy regimen were randomly assigned on a 2:1 schedule to receive no more than six cycles of cisplatin plus cetuximab or cisplatin alone. Patients receiving cisplatin alone could switch to cisplatin plus cetuximab or cetuximab alone on disease progression. The primary end point was overall response rate (ORR). Secondary end points studied included progression-free survival (PFS), overall survival (OS), and safety profiles. Analyses included a significance level of α = .10 with no adjustments for multiplicity. Results The full analysis set comprised 115 patients receiving cisplatin plus cetuximab and 58 receiving cisplatin alone; 31 patients whose disease progressed on cisplatin alone switched to cetuximab-containing therapy. The ORR was 20% (95% CI, 13 to 29) with cisplatin plus cetuximab and 10% (95% CI, 4 to 21) with cisplatin alone (odds ratio, 2.13; 95% CI, 0.81 to 5.59; P = .11). Cisplatin plus cetuximab resulted in longer PFS compared with cisplatin alone (median, 3.7 v 1.5 months; hazard ratio [HR], 0.67; 95% CI, 0.47 to 0.97; P = .032). Corresponding median OS was 12.9 versus 9.4 months (HR, 0.82; 95% CI, 0.56 to 1.20; P = .31). Common grade 3/4 adverse events included acne-like rash, neutropenia, and fatigue. Conclusion While the primary study end point was not met, adding cetuximab to cisplatin doubled the ORR and appeared to prolong PFS and OS, warranting further investigation in mTNBC.

Background: The epidermal growth factor receptor (EGFR) plays a role in triple-negative (estrogen receptor-, progesterone receptor-, HER2-negative) breast cancer (TNBC). This randomized, phase II study investigated the combination of the EGFR monoclonal antibody cetuximab and cisplatin in the treatment of metastatic (m) TNBC. Methods: Patients (pts) with mTNBC who had received ≥1 prior chemotherapy regimen for metastatic disease, were randomized 2:1 to treatment with either: cetuximab (400 mg/m2 initial dose then 250 mg/m2 weekly) + ≥6x 3-weekly cycles of cisplatin (75 mg/m2, d1); or ≥6x 3-weekly cycles of cisplatin alone. In the cisplatin arm, pts with disease progression (PD) during the 6 cisplatin cycles could switch to cetuximab plus cisplatin and those with PD after the 6 cycles could receive cetuximab alone. The primary endpoint was best overall response. Simultaneous null hypotheses assumed that the overall response rate (ORR) in the combination arm was ≥20% and that the ORRs were equal in both arms. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. All statistical tests were performed at alpha-level 0.1 Results: 173 pts were included in the intention-to-treat population: 115 were randomized to cetuximab/cisplatin and 58 to cisplatin. The cetuximab/cisplatin and cisplatin arms were well balanced for patient and disease characteristics (randomization strata, 73% first and 27% second line in both arms). Differences included: age ≥65 years (19.1% vs 12.1%) and lung metastases (55.7% vs 44.8%). 30 pts receiving cisplatin alone switched to cetuximab/cisplatin after first PD. 79.6% of patients on cetuximab/cisplatin and 73.7% on cisplatin received ≥90% of the relative dose intensity of cisplatin. Adverse events (AEs) were manageable and in line with what was expected from the different agents (grade 3/4 AEs are shown in the Table). Grade 3/4 AEs (%) Adding cetuximab to cisplatin nearly doubled the ORR: 20.0% (95% CI 13.1%, 28.5%) vs 10.3% (95% CI 3.9%, 21.2%) (p=0.5 for testing ORR against 20.0%), with an odds ratio of 2.126 (90% CI 0.945, 4.786, p=0.11). Cetuximab/cisplatin was associated with a significant 32.5% reduction in the risk of disease progression compared with cisplatin alone HR 0.675 (95% CI 0.470, 0.969, p=0.032). Median PFS times were 3.7 and 1.5 months, respectively. The benefits of cetuximab/cisplatin over cisplatin on ORR and PFS were observed consistently across sub-groups (according to patient, disease and treatment characteristics), but sample sizes were small. OS results will be presented at the meeting. Conclusions: Adding cetuximab to cisplatin increased the ORR compared with cisplatin alone and significantly improved PFS in mTNBC. Safety was manageable. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD01-01.

Background: Triple negative breast cancer (TNBC) has the worst prognosis amongst all subtypes. Studies have shown that the achievement of pathologic complete response in the breast and axilla correlates with improved survival.The aim of this study was to identify clinical or pathological features of real-life TNBC patients with a higher risk of early relapse.Materials and methods: Single-centre retrospective analysis of 127 women with TNBC, stage II-III, submitted to neoadjuvant treatment and surgery between January 2016 and 2020. Multivariate Cox regression analysis for disease free survival (DFS) at 2 years was performed and statistically significant variables were computed into a prognostic model for early relapse.Results: After 29 months of median follow-up, 105 patients (82.7%) were alive and, in total, 38 patients (29.9%) experienced recurrence. The 2-year DFS was 73% (95% CI: 21.3-22.7). In multivariate analysis, being submitted to neoadjuvant radiotherapy [HR 2.8 (95% CI: 1.2-6.4), p = 0.017] and not achieving pathologic complete response [HR 0.3 (95% CI: 0.1-1.7), p = 0.011] were associated with higher risk of recurrence. In our prognostic model, the presence of at least one of these variables defined a subgroup of patients with a worse 2-year DFS than those without these features (59% vs. 90%, p < 0.001, respectively). Conclusions:In this real-life non-metastatic TNBC cohort, neoadjuvant radiotherapy (performed due to insufficient clinical response to neoadjuvant chemotherapy or significant toxicity) impacted as an independent prognostic factor for relapse along with the absence of pathologic complete response identifying a subgroup of higher risk patients for early relapse that might merit a closer follow-up.

BACKGROUND Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumour in adults. The current standard of care for newly diagnosed GBM is maximal surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide (TMZ). This study aimed to evaluate the survival outcomes and identify predictors of survival among these patients. MATERIAL AND METHODS We performed a single-centre retrospective analysis of GBM patients treated with radiotherapy plus concomitant and adjuvant TMZ from 2013 to 2020. The analyses of progression-free survival (PFS) and overall survival (OS), each one evaluated starting from initial diagnosis, were performed. Survival curves were estimated with the Kaplan- Meier method and compared using the log-rank test. RESULTS Fifty-eight patients were identified. The median age was 61 years (range 18- 80), 51 (88%) patients were in ECOG-PS 0–1, 6 (10%) patients had isocitrate dehydrogenase (IDH) mutation and 53 (91%) of patients had undergone debulking surgery. At a median follow-up of 21 months, median OS was 12.8 months (95% confidence interval [CI] 9.7–15.9), whereas median PFS was 9.5 months (95% CI 8.5–10.5). The 1-year survival rate was 42% and the 2-year survival rate was 10%. Grade 3 or 4 hematologic toxicity occurred in 11 (19%) patients. Twenty-five (42%) patients completed at least 6 cycles of TMZ monotherapy with statistically significant differences between this sub-group and those who weren’t able to continue TMZ monotherapy [median OS 19.3 months (95% CI 14.4–24.2) vs 10.6 months (95% CI 7.8–13.4) p&lt;0.001]. ECOG-PS = 0 [median OS 16.7 months (95% CI 13.4–20.0, p=0.001)] and patients under 65 years of age [median OS 15.6 months (95% CI 12.3–18.9, p=0.02) were associated with significantly better median OS. CONCLUSION The current standard of care treatment for GBM remains poor. An important factor predictor of survival is the completion of the 6 maintenance cycles of TMZ. At baseline, ECOG PS and the patient’s age could be used to define patient prognosis.

Background Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, and it is associated with a poor prognosis in the elderly. The current standard of care for newly diagnosed GBM is maximal surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide (TMZ). In elderly patients with GBM, short-courses of radiotherapy with TMZ are used. Material and Methods We performed a single-center retrospective analysis of elderly GBM patients treated from 2013 to 2020. The primary endpoint was to evaluate progression free survival (PFS) and overall survival (OS) according to treatment received (TMZ and standard radiotherapy (60 Gy over a period of 6 weeks) vs TMZ and short-course radiotherapy (40 Gy in 15 fractions)). Secondary endpoints were analysis of population demographics and major toxicities associated to treatment. Results Twenty-two patients were identified. The median age was 72 years (range 65- 80), 18 (85.7%) patients were in ECOG-PS 0-1, 12 (57.1%) were males and all patients had undergone partial or complete resection surgery. Eleven (52.4%) patients received TMZ and standard radiotherapy and 10 (47.6%) patients received TMZ and short-course radiotherapy. Three (14.3%) patients had complete remission, 11 (52.4%) patients had partial response, 2 (9.5%) patients presented stable disease and 5 (23.8%) patients had disease progression. Median OS was 9 months (95% CI, 3.6 to 14.4) with TMZ with standard radiotherapy and 8 months (95% CI, 1.8 to 14.2) with TMZ and short-course radiotherapy (p=0.322). Median PFS was 5 months (95% CI, 2.8 to 7.2) with TMZ with standard radiotherapy and 6 months (95% CI, 3.1 to 8.9) with TMZ and short-course radiotherapy (p=0.944). Most common toxicities were hematological, with 5 (23.8%) patients presented thrombocytopenia grade 2 or higher. Five (23.8%) patients presented grade 3/4 toxicities (2 (9.5%) patients presented thrombocytopenia grade 4, 1 (4.8%) patient presented thrombocytopenia grade 3, and 2 (9.5%) patients presented anemia grade 3. Conclusion The prognosis of GBM remains poor besides standard therapy. TMZ and short-course radiotherapy should be an option in elderly patients due to its non-inferiority. Elderly patients should undergo a careful geriatric evaluation before starting treatment.

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Background: Breast cancer (BC) survivors report adverse sexual effects such as disrupted sexual function (SF) and sexual distress. Despite its high prevalence, sexual dysfunction (SD) is not effectively screened for or treated.

Purpose Significant changes in treatment centers were implemented during COVID-19 pandemics. Understanding how these alterations impacted cancer patients is a subject that needs to be investigated. Methods Patients who accepted to fill a hand paper questionnaire were included in this cross-sectional study. The questionnaire was distributed between March 19 and April 30, 2020 (first emergency state in Portugal) at the Portuguese Oncology Institute of Coimbra Francisco Gentil. Results A total of 100 patients participated in the study, of whom 66% were female. The median age was 61 years old [29–89]. Patients presented low education levels (65% with 9 or less years of schooling), lived together (83%) and were undergoing palliate treatments (59%). The most significant reported change in health care were inability of having an accompanying person in medical appointments (64%). Association with the level of education, household, type of solid cancer or therapeutic purpose was not verified (Creamer-V-indicator < 0.4). The major concerns reported were being infected by SARS-Cov-2 due to an immunosuppressed state (65%) and the security of self/family/friends (53%). Patients with lower education were more worried about developing COVID-19 (p = 0.001) and of having limited access to medical care (p = 0.047). Patients in a curative therapeutic approach were more concerned about employment situation (p = 0.031) and had higher anxiety levels (p = 0.047). Conclusion COVID-19 pandemic is having a great impact in patients with cancer, namely in those who have a lower education level, live alone or those who therapeutic approach is curative. The implementation of measures to manage the psychologic impact of COVID-19 is urgent.