Browsing by Author "Werutsky, G"

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Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]
(Elsevier B.V., 2024) de, Azambuja, E; Piccart-Gebhart, M; Fielding, S; Townend, J; Hillman, DW; Colleoni, M; Roylance, R; Kelly, CM; Lombard, J; El-Abed, S; Choudhury, A; Korde, L; Vicente, M; Chumsri, S; Rodeheffer, R; Ellard, SL; Wolff, AC; Holtschmidt, J; Lang, I; Untch, M; Boyle, F; Xu, B; Werutsky, G; Tujakowski, J; Huang, C-S; Baruch, NB; Bliss, J; Ferro, A; Gralow, J; Kim, S-B; Kroep, JR; Krop, I; Kuemmel, S; McConnell, R; Moscetti, L; Knop, AS; van, Duijnhoven, F; Gomez, H; Cameron, D; Di, Cosimo, S; Gelber, RD; Moreno-Aspitia, A
Background: Dual anti-human epidermal growth factor receptor 2 (HER2) blockade has improved the outcomes of patients with early and metastatic HER2-positive breast cancer. Here we present the final 10-year analysis of the ALTTO trial. Patients and methods: The ALTTO trial (NCT00490139) is a prospective randomized, phase III, open-label, multicenter study that investigated the role of adjuvant chemotherapy and trastuzumab alone, in combination or sequentially with lapatinib. The primary endpoint was disease-free survival (DFS) and secondary endpoints included overall survival (OS), time to distant recurrence and safety. Results: Overall, 6281 patients with HER2-positive early breast cancer were included in the final efficacy analysis in three treatment groups: trastuzumab (T), lapatinib + trastuzumab (L + T) and trastuzumab followed by lapatinib (T→L). Baseline characteristics were well balanced between groups. At a median follow-up of 9.8 years, the addition of lapatinib to trastuzumab and chemotherapy did not significantly improve DFS nor OS. The 10-year DFS was 77% in T, 79% in L + T and 79% in T→L, and the 10-year OS was 87%, 89% and 89%, respectively. The incidence of any cardiac event was low and similar in the three treatment groups. Conclusions: With a longer follow-up, no significant improvement was observed in DFS in patients treated with dual anti-HER2 blockade with lapatinib + trastuzumab compared to trastuzumab alone. The 10-year survival rates for the combination group are consistent with other studies that have explored dual anti-HER2 therapy.
Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
(American Society of Clinical Oncology, 2021) Lara Gongora, AB; Werutsky, G; Jardim, DL; Nogueira-Rodrigues, A; Barrios, CH; Mathias, C; Maluf, F; Riechelmann, R; Fraga, M; Gomes, H; William, WN; Yamada, CAF; de Castro, G Jr; Rosa, DD; de Melo, AC; Sala, R; Bustamante, E; Bretel, D; Arrieta, O; Cardona, AF; Bastos, DA
Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments.Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group.Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.
Socioeconomic Impact of Cancer in Latin America and The Caribbean: Socioeconomic Impact of Cancer in Latin America
(Elsevier Inc., 2022) Werutsky, G; Gössling, G; Pellegrini, RA; Ampuero, GAS; Rebelatto, T
The incidence of cancer in Latin America and the Caribbean (LAC) is increasing yearly and is expected to reach 2.4 million new cases by 2040, with a more pronounced effect in Central America and South America. In addition, cancer is already the most frequent cause of premature death for most countries in LAC, and the second cause of death independent of country socioeconomic status, clearly demonstrating that the cancer burden in LAC should be addressed now rather than considered as an issue to be dealt with in the future. LAC countries performed in a mid-range zone in terms of income and mortality-to-incidence ratio compared to other countries globally. The LAC continent has, in general, a median income per capita and a median availability of radiotherapy (RDT) machines per capita. Patients that have private health coverage are more likely to receive preventive care such as pap smears and mammography in many countries of the LAC. The human development index was negatively related to mortality from oral cancer in the LAC countries with medium and low Human Development Index (HDI). Cancer treatment adverse events can negatively affect survivors’ workability compromising their return to work after diagnosis. In conclusion, the cancer burden can be a major public health issue with a considerable socioeconomic impact in LAC countries. It is demonstrated in several studies that unequal access to optimal care is frequent in LAC and that health insurance type may impact patients’ diagnosis and outcome.