Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial

Abstract

ObjectiveThe CIRCE trial (NCT 01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB–IVA). The impact of both treatment arms on quality of life is reported in the present study.MethodsPatients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB–IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann–Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors.ResultsA total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75–86.5% in the chemoradiation arm vs 55–81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms.ConclusionAfter treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients’ quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.

Prognostic significance of the Central Tumor Size (CTS) in Cervical Cancer (CC) stages IIb and IIIb: What should we do with the FIGO staging system and therapeutic strategies?

“…Based on our investigation, we underline that overall survival and disease free survival decrease when the central tumor is over 6 cm, and even more when they are over 8 cm, regardless of the treatment option [2]. McConmark in 2013 [28] published encouraging results using neoadjuvant chemotherapy followed by concurrent chemoradiation in locally advanced disease with central bulky tumors [28], as well as other authors [29,30], arrived to similar conclusions, also considering the quality of life of these patients [31]. At this time, it is important to remember that was proven no difference between neoadjuvant chemotherapy vs. chemoradiation [32,33].…”

Quality of Life among Survivors of Locally Advanced Cervical Cancer Treated with Definitive Chemoradiotherapy in a Decade of Transition

“…37 In our review, the EORTC QLQ-C30 and CX24 were the most commonly used tools in evaluating health-related and disease-specific QoL. 19,22,23,[25][26][27] Two papers characterized the temporal evolution of health-related QoL among LACC survivors. 19,21 One reported improvement at 12, 24, and 36 months.…”

“…Age was a determinant for body image, sexual activity, and menopausal symptoms. 22 Age, stage, and baseline symptom distress levels were determinants for long-term symptom distress. 21 Baseline physical condition, which was measured using the EORTC QLQ-C30 functioning scale, predicted the development of dyspnea.…”

“…The number and quality of studies included in our review reflect the relative paucity of high-quality literature on longterm QoL among LACC survivors. Of the nine papers included in this review, one 19 is a multinational study; six [20][21][22][25][26][27] come from upper-middle or high income countries, namely, Brazil, Canada, Italy, Bosnia and Herzegovina, and Thailand; and two 23,31 come from a lower-middle income country, India. 56 The studies include three small (<50) cross-sectional studies, 20,27,31 one (n ¼ 67) retrospective study, 21 and three small (<60) prospective studies.…”

LINC00294 induced by GRP78 promotes cervical cancer development by promoting cell cycle transition

“…However, chemotherapy drugs cannot achieve a good therapeutic effect in cervical cancer due to drug resistance. In addition, effective treatments for advanced and recurrent cervical cancer are lacking ( 3 ). However, targeted therapy for cervical cancer has been well recognized.…”