Page 44 - ARNM-1-1

Advances in Radiotherapy
& Nuclear Medicine CCRT plus nimotuzumab for cervical cancer

2.3. Evaluation and follow-up Table 1. Characteristics of patients (n=34)

We evaluated therapeutic efficacy by imaging (MRI and No. Percentage
CT) and gynecological examinations 1 and 4 months after Initial stage (FIGO 2009)
treatment. Re-examination was performed every 3 months IB1 1 2.9
within 2 years, every 6 months within 3 – 5 years, and
every year thereafter. All evaluation was based on response IB2 6 17.6
evaluation criteria in solid tumors 1.1 . IIA2 6 17.6
[10]
IIB 13 38.2
Complete remission (CR) was defined as the
disappearance of all target lesions and a reduction in the IIIB 5 14.7
short diameter of all pathological lymph nodes to <10 IVA 3 8.8
mm. Partial remission (PR) was defined as a reduction Pathological type squamous cell carcinoma 34 100
in the total diameter of the target lesions by at least 30% Maximum diameter of tumor (cm) 4.83±1.13 Not applicable
compared to the baseline level. Progressed disease (PD) Parametrial involvement 18 52.9
was defined as an increase in the total diameter of the Pelvic lymph node metastases 22 64.7
target lesions by at least 20% compared to the minimum Para-aortic lymph node metastases 8 23.5
value of the sum of the target lesion diameters. Meanwhile,
the absolute value of the sum of diameter must increase by
5 mm (the presence of one or more than one new lesion only completed 4–5 sessions of concurrent chemotherapy
was also regarded as PD). Stable disease was defined as the due to bone marrow suppression or numbness.
reduction of target lesions between PR and PD. Disease- RT lasted more than 8 weeks in 23.5% (8/34) of
free survival (DFS) time was defined as the time from patients and 31.0% (12/34) underwent four cycles of
CR to disease progression or the last follow-up or death. adjuvant chemotherapy. One patient required a surgical
Progression-free survival (PFS) time was defined as the hysterectomy 6 months after RT, and the post-operative
time from the beginning of treatment to tumor progression pathological result was negative.
or the last follow-up or death. Local PFS was defined as
the time from the beginning of treatment to local tumor 3.2. Side effects
progression or the last follow-up or death. Overall survival Acute side effects noted during the concurrent treatment
(OS) time was defined as the time from the beginning of are shown in Table 2. One patient experienced a sensation
treatment to death. The side effect was evaluated according of numbness developing from the back to lower limbs
to the common terminology criteria for adverse events when treated with cisplatin and nimotuzumab on the 1 st
4.03 standard, which was defined as acute reactions within day. Thereafter, treatment with cisplatin was stopped, but
90 days after RT and chronic reactions more than 90 days nimotuzumab was continued until the end of treatment.
after RT.
Twenty of the 34 patients showed late toxicities (Table 3).
2.4. Statistical analysis One patient developed vaginal and rectal fistulas 6
months after RT and underwent a colostomy. There was
SPSS 21.0 software was used for data analysis. Kaplan– one case of intestinal obstruction 4 months after RT,
Meier method and log-rank test were used for the survival which was treated by performing surgery. One patient
analysis. The counting method was used for side effect developed a Grade 2 rectal hemorrhage 7 months after
analysis. P < 0.05 was considered statistically significant.
RT. There were two cases of Grade 3 vaginal stenosis.
3. Results Grade 2 hematuria occurred 2 and 3.8 years after RT in
two cases, respectively.
3.1. General information
In total, 34 patients were enrolled in this study. The 3.3. Efficacy
median age of the patients was 52 (37–67) years. Karnofsky The CR rate was 97.1% (33/34). The DFS, local progression-
performance status scores were in the range of 70–100. free survival, and OS rates were 79.4%, 91.2%, and 82.4%,
More detailed information is shown in Table 1. The respectively. The corresponding 5-year values were 79.4%,
follow-up time was 13–98 months (median 66 months). 91.2%, and 79.3% (Figures 1-3). Among the 34 patients,
All patients received EBRT, HDR brachytherapy, and seven showed disease progression, including three patients
concurrent therapy with nimotuzumab 6 times. Among who showed local progression or recurrence; three who
the included patients, eight with para-aortic lymph node showed distant metastasis to the lung, supraclavicular
metastasis received pelvic extended RT. Seven patients lymph nodes, and bone, respectively; and one in whom

Volume 1 Issue 1 (2023) 3 https://doi.org/10.36922/arnm.0408