Abstract
Objective : to evaluate tolerability and efficacy of maintenance treatment in the absence of progression after 16 weeks of first-line therapy in patients with unresectable metastatic colon cancer. Materials and methods . We have analyzed medical case histories of patients with metastatic colorectal cancer who underwent treatment in the department of clinical pharmacology and chemotherapy of N. N. Blokhin Russian Cancer Research Center from 2007 to 2015 years. Inclusion criteria were the following: 16–24 weeks of first-line chemotherapy with no signs of progression and the inability to perform metastasectomy. Progression-free survival was the main criterion for effectiveness in our study. Results. 160 (44.5 %) of 359 treated patients met the inclusion criteria. 102 (63.7 %) patients were followed up, while the other 58 (36.3 % – comparison group) patients underwent maintenance chemotherapy. Grade I–II toxic reactions and grade III complications associated with first-line chemotherapy were insignificantly more common in the group of patients left on maintenance chemotherapy: 72.4 % and 37.9 % versus 57.8 % and 24.5 % in the comparison group, p = 0.07 and p = 0.07 respectively. The frequency of grade I–II toxic reactions and grade III complications in the second-line treatment did not differ between treatment groups (p = 0.9 and p = 0.8). The median of progression-free survival in observation group and comparison group was 4, and 6 months (odds ratio (OR) 0.6; p = 0.009), and life expectancy – 23 and 31 months (OR 0.75; p = 0.1), respectively. Statistically significant differences between groups with respect to achieving the objective response and/or normalization of carcinoembryonic antigen level were revealed: median of progression-free survival was 13 (n = 26 of 57; 45.6 %) and 4 months (n = 31 of 57, 54.4 %), respectively (HR 0.38; p = 0.002), median of life expectancy – 34 months versus 26 months (OR 0.37; p = 0.3). Conclusions . Carrying out maintenance therapy is associated with increased incidence of grade III complications during the first-line treatment, but does not affect the tolerability of the second-line treatment. Supportive chemotherapy with fluoropyrimidines remains to be the most effective in patients with favorable prognostic factors such as normalization of carcinoembryonic antigen and/or achievement of the objective response on the background of first-line chemotherapy.
Highlights
Progression-free survival was the main criterion for effectiveness in our study
Grade I–II toxic reactions and grade III complications associated with first-line chemotherapy were insignificantly more common in the group of patients left on maintenance chemotherapy: 72.4 % and 37.9 % versus 57.8 % and 24.5 % in the comparison group, p = 0.07 and p = 0.07 respectively
The frequency of grade I–II toxic reactions and grade III complications in the second-line treatment did not differ between treatment groups (p = 0.9 and p = 0.8)
Summary
Целью нашей работы явилась оценка переносимости и эффективности проведения поддерживающей терапии при отсутствии прогрессирования после 16 нед 1-й линии терапии у больных метастатическим неоперабельным раком толстой кишки. Критериями включения больных в анализ явились: проведение 16–24 нед химиотерапии 1-й линии без признаков прогрессирования и невозможность выполнения метастазэктомии. Критериями включения больных в группе с наблюдением чаще выполнялось удаление в анализ являлись проведение ХТ 1-й линии в течение первичной опухоли, резекция метастазов в анамнезе, 16–24 нед без признаков прогрессирования и невоз- реже встречались пациенты с поражением метастазами можность выполнения метастазэктомии. Медиана ВБП осложнения III степени тяжести в виде ладонно-подо- в группах наблюдения и поддерживающей терапии швенного синдрома и у 1 (1,7 %) – повышение уровня составила 4 и 6 мес (отношение рисков (ОР) 0,6; 95 %. При сравнении прогностических групп медиана ВБП составила 6 и 4 мес в группе благо-
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