FASE II TRIAL OF NEOADJUVANT CHEMOTHERAPY FOLLOWED BY CHEMORADIATION IN LOCALLY ADVANCED CERVICAL CANCER

Author(s):  
Carla Rameri Azevedo
2021 ◽  
Vol 2021 (7) ◽  
Author(s):  
Antonios Athanasiou ◽  
Sarah J Bowden ◽  
Evangelos Paraskevaidis ◽  
T S Shylasree ◽  
Kostas Lathouras ◽  
...  

1994 ◽  
Vol 12 (11) ◽  
pp. 2309-2316 ◽  
Author(s):  
G Scambia ◽  
P Benedetti Panici ◽  
E Foti ◽  
M Amoroso ◽  
G Salerno ◽  
...  

PURPOSE The aim of the study was to investigate the role of squamous cell carcinoma antigen (SCC) in the management of patients with locally advanced cervical cancer treated by neoadjuvant chemotherapy and radical surgery. PATIENTS AND METHODS SCC assay was performed with a radioimmunoassay kit in a series of 102 patients with locally advanced cervical cancer. The values of 2.5, 5, and 7 ng/mL were used to define SCC antigen positivity. The chi 2 and Fisher's exact test and the stepwise logistic regression were used to evaluate the distribution of marker values. Analysis of survival was performed using the Kaplan and Meier test and Cox multivariate regression analysis. RESULTS SCC levels were elevated in 65%, 45%, and 32% of patients with primary tumors for cutoff values of 2.5, 5, and 7 ng/mL, respectively. SCC pretreatment levels correlated with stage, tumor volume and lymph node status. In the multivariate analysis, SCC expression proved to be an independent predictor of response to neoadjuvant chemotherapy. SCC posttreatment levels were strongly related to chemotherapy response. Moreover, the overall correlation between the clinical course of the disease and the variation of SCC levels was 83%. In patients with squamous cell tumors, survival was significantly longer in SCC-negative cases compared with SCC-positive cases (P = .04). Moreover, in patients undergoing surgery after response to neoadjuvant chemotherapy, low SCC values were associated with better prognosis (P = .02). In the multivariate analysis, parametrial involvement and SCC status proved to retain an independent prognostic value. CONCLUSION Our data show that SCC assay may provide useful information to improve the prognostic characterization and disease monitoring of patients with locally advanced cervical cancer undergoing neoadjuvant chemotherapy.


2021 ◽  
Author(s):  
Xiao-Li Yu ◽  
Miao-Fang Wu ◽  
Lin Ding ◽  
Jin Yang ◽  
Shou-Min Bai

Abstract Background: This study was aimed to determine the effect of neoadjuvant chemotherapy consisting of nab-paclitaxel and cisplatin (NACT-nPC) in patients with locally advanced cervical cancer.Materials and Methods: The consecutive, newly diagnosed, non-metastatic and locally advanced cervical cancer patients were retrospectively recruited between October 2016 and June 2020 in our hospital. All patients received concurrent chemoradiotherapy alone or following neoadjuvant chemotherapy. Patients were divided into two groups: one receiving NACT-nPC, and the control group receiving no or other regimes of neoadjuvant chemotherapy. We compared the complete remission rate of primary tumor at the end of external radiotherapy and chemoradiotherapy between the two groups. Results: A total of 198 patients were enrolled in this study, including 60 in NACT-nPC group and 138 in control group. At the end of external radiotherapy, 27 patients in NACT-nPC group and 32 patients in control group achieved complete remission (P = 0.002). At the end of chemoradiotherapy, 56 patients in NACT-nPC group and 114 patients in control group achieved complete remission (P = 0.033). The acute side effects above grade 3 in NACT-nPC group was 41.7% (25/60) and manageable, lower than control group which was 77/138 (55.8%).Conclusions: NACT-nPC can improve the complete response rate of patients with locally advanced cervical cancer followed by concurrent chemoradiotherapy, and the toxicity is tolerable. Furthermore, we suspect the NACT-nPC can improve the survival of the patients. However, further prospective studies are needed to confirm this result.


2019 ◽  
Vol 37 (33) ◽  
pp. 3124-3131 ◽  
Author(s):  
Samantha Cabral S. da Costa ◽  
Renata Colombo Bonadio ◽  
Flavia Carolina G. Gabrielli ◽  
Andrea S. Aranha ◽  
Maria Luiza N. Dias Genta ◽  
...  

PURPOSE Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Additional treatment strategies are required to improve outcomes. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by CRT. METHODS In this phase II trial, patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) were randomly assigned to three cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life. RESULTS From 107 patients enrolled in the trial, 55 were randomly assigned to the NAC arm and 52 to the CRT-alone arm. The majority of patients had squamous cell carcinoma (87.8%). After a median follow-up of 31.7 months, NAC was associated with an inferior PFS, with 3-year PFS rates of 40.9% v 60.4% in the CRT arm (hazard ratio, 1.84; 95% CI, 1.04 to 3.26; P = .033). NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006). After treatment completion, complete response rates were 56.3% in the NAC arm and 80.3% in the CRT arm ( P = .008). Toxicities were similar in both arms, with the exception of hypomagnesemia and neuropathy being more common with NAC. CONCLUSION This study shows that the addition of NAC consisting of cisplatin and gemcitabine to standard CRT is not superior and is possibly inferior to CRT alone for the treatment of LACC.


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