A Randomized Comparison of Cisplatin and Oral Vinorelbine as Radiosensitizers in Aged or Comorbid Locally Advanced Cervical Cancer Patients

2013 ◽  
Vol 23 (5) ◽  
pp. 884-889 ◽  
Author(s):  
Jaime Alberto Coronel ◽  
Lucely del Carmen Cetina ◽  
David Cantú ◽  
Oscar Cerezo ◽  
Cintia Sánchez Hernández ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Treatment Time ◽  
External Beam Radiotherapy ◽  
Randomized Study ◽  
Locally Advanced ◽  
Advanced Cervical Cancer ◽  
Overall Treatment Time ◽  
Aged Patients ◽  
Oral Vinorelbine ◽  
Locally Advanced Cervical Cancer

ObjectiveChemoradiation with cisplatin is considered the standard of care for patients with locally advanced cervical cancer; however, cisplatin could be difficult to use in aged patients or patients with comorbidities such as diabetes mellitus and blood hypertension; hence, it is important to investigate nonplatinum drugs for radiosensitization. In addition, oral cytotoxics may overcome the drawbacks of intravenous infusions and could be of easier administration.MethodsIn this small randomized trial, we tested cisplatin against oral vinorelbine as radiosensitizers in these patients. A total of 39 patients 65 years or older or diabetic and hypertensive patients of any age were randomized to cisplatin or oral vinorelbine at 40 mg/m2 or 60 mg/m2, respectively. Both drugs were administered weekly for 6 courses during pelvic external-beam radiotherapy and brachytherapy radiation. Efficacy and safety were assessed.ResultsNineteen patients received oral vinorelbine, and 20 patients received cisplatin. The median cumulative dose to point A was 80.8 Gy for both groups, and the overall treatment time was 48 (42–54) and 50 (43–55) days for vinorelbine and cisplatin groups, respectively. Patients in both arms received a median of 5 applications of chemotherapy. Treatment was well tolerated in both arms. The most frequent toxicity in both arms was lymphopenia grades 2 and 3. At a median follow-up time of 16 months (4–19), there were no differences in either progression-free survival or overall survival between groups.ConclusionsOur results suggest that these patient populations can safely be treated with either cisplatin or navelbine as radiosensitizers; however, a larger randomized study is needed to demonstrate the noninferiority of oral vinorelbine as an easier and practical alternative for radiosensitization in cervical cancer.

ENGOT-cx11/KEYNOTE-A18: A phase III, randomized, double-blind study of pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6096-TPS6096
Author(s):  
Domenica Lorusso ◽  
Nicoletta Colombo ◽  
Robert L. Coleman ◽  
Leslie M. Randall ◽  
Linda R. Duska ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
High Risk ◽  
External Beam Radiotherapy ◽  
Locally Advanced ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind Study ◽  
Advanced Cervical Cancer ◽  
Double Blind ◽  
Locally Advanced Cervical Cancer

TPS6096 Background: High-risk locally advanced cervical cancer has a poor prognosis, and more than half of patients recur in 2 y. External beam radiotherapy (EBRT) with concurrent chemotherapy followed by brachytherapy is the standard of care for locally advanced cervical cancer. The immunostimulatory activity of the PD-1 inhibitor pembrolizumab (pembro) may be enhanced by concurrent chemoradiotherapy (CRT). After the KEYNOTE-158 study, in which pembro showed durable antitumor activity, pembro monotherapy was approved for patients with PD-L1–positive recurrent or metastatic cervical cancer who progressed during or after chemotherapy. ENGOT-cx11/KEYNOTE-A18 (NCT04221945) is a phase III, randomized, placebo-controlled study evaluating pembro with concurrent CRT for the treatment of locally advanced cervical cancer. Methods: Approximately 980 patients with high-risk (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA), locally advanced, histologically confirmed cervical cancer who have not received systemic therapy, immunotherapy, definitive surgery, or radiation will be randomized 1:1 to receive either 5 cycles of pembro 200 mg every 3 wk (Q3W) + CRT followed by 15 cycles of pembro 400 mg Q6W or 5 cycles of placebo Q3W + CRT followed by 15 cycles of placebo Q6W. The CRT regimen includes 5 cycles (with optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT followed by brachytherapy. Randomization is stratified by planned EBRT type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), cancer stage at screening (stage IB2-IIB vs III-IVA), and planned total radiotherapy dose. Treatment will continue until the patient has received 20 cycles of pembro (5 cycles 200 mg Q3W, 15 cycles 400 mg Q6W) vs placebo (~2 y) or until disease progression, unacceptable toxicity, or withdrawal. Primary endpoints are PFS per RECIST v1.1 by blinded independent central review and OS. Secondary endpoints are PFS at 2 y, OS at 3 y, complete response at 12 wk, ORR, PFS and OS in PD-L1–positive patients, EORTC QLQ-C30 and QLQ-CX24, and safety. Enrollment is ongoing. Clinical trial information: NCT04221945.

scholarly journals Computed Tomography–Guided Interstitial Brachytherapy for Locally Advanced Cervical Cancer: Introduction of the Technique and a Comparison of Dosimetry With Conventional Intracavitary Brachytherapy

2017 ◽  
Vol 27 (4) ◽  
pp. 768-775 ◽  
Author(s):  
Zhong-Shan Liu ◽  
Jie Guo ◽  
Yang-Zhi Zhao ◽  
Xia Lin ◽  
Bing-Ya Zhang ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Cervical Cancer ◽  
External Beam Radiotherapy ◽  
Locally Advanced ◽  
High Dose ◽  
External Beam ◽  
Advanced Cervical Cancer ◽  
3 Dimensional ◽  
Locally Advanced Cervical Cancer ◽  
The Mean

ObjectiveWe present a new technique of 3-dimensional computed tomography–guided interstitial (IS) brachytherapy (BT) for locally advanced cervical cancer, offering a more advantageous clinical treatment approach.Materials/MethodsInterstitial BT was performed using an applicator combining uterine tandem and metal needles; needles were inserted freehand under real-time 3-dimensional computed tomography guidance. Twenty-eight patients with bulky tumors and/or parametrial extension (tumor size > 5 cm) after external beam radiotherapy received IS BT. Dosimetric outcomes of the IS BT including the total dose (external beam radiotherapy and high dose-rate BT) D90 for the high-risk clinical target volume (HR-CTV) and D2cc for the organs at risk (OARs) were investigated and compared with a former patient group consisting of 30 individuals who received the conventional intracavitary (IC) BT.ResultsThe mean D90 values for HR-CTV in the IC BT and IS BT groups were 76.9 ± 5.7 and 88.1 ± 3.3 Gy, respectively. Moreover, 85.7% of the patients received D90 for HR-CTV of 87 Gy or greater in the IS BT group, and only 6.7% of the patients received D90 for HR-CTV of 87 Gy or greater in the IC BT group. The D2cc for the bladder, rectum, and sigmoid were 84.7 ± 6.8, 69.2 ± 4.2, and 67.8 ± 4.5 Gy in the IC BT group and 81.8 ± 6.5, 66.8 ± 4.0, and 64.8 ± 4.1 Gy in the IS BT group. The mean number of needles was 6.9 ± 1.4, with a mean depth of 2.9 ± 0.9 mm for each IS BT. Interstitial BT was associated with only minor complications.ConclusionsThe IS BT technique resulted in better dose-volume histogram parameters for large volume tumors (>5 cm) compared with the conventional IC BT and acceptable risk of acute complications in locally advanced cervical cancer and is clinically feasible.

scholarly journals Anatomic Location of PET-Positive Aortocaval Nodes in Patients with Locally Advanced Cervical Cancer: Implications for Surgical Staging

2012 ◽  
Vol 22 (7) ◽  
pp. 1203-1207 ◽  
Author(s):  
Michael Frumovitz ◽  
Pedro T. Ramirez ◽  
Homer A. Macapinlac ◽  
Ann H. Klopp ◽  
Alpa M. Nick ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Randomized Study ◽  
Locally Advanced ◽  
Stage Iv ◽  
Surgical Staging ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Pathologic Evaluation ◽  
Positron Emission ◽  
Number Of Patients

ObjectivePathologic evaluation of aortocaval nodes in patients with locally advanced cervical cancer in an effort to better tailor radiotherapy has gained popularity. We sought to determine which aortocaval nodes should be sampled during surgical staging procedures.MethodsFrom 2004 to 2011, 246 patients with locally advanced cervical cancer underwent positron emission tomography (PET) before definitive chemoradiation. We reviewed the imaging studies to determine the location of PET-positive aortocaval nodes in relationship to the inferior mesenteric artery (IMA).ResultsForty-two patients (17%) had PET images suggesting aortocaval metastasis. Ten patients had stage IB, 1 had stage IIA, 13 had stage IIB, 13 had stage IIIB, and 5 had stage IV disease. Of these 42 patients, 39 (93%) had FDG-avid pelvic nodes, 1 (2%) had PET-negative pelvic nodes but FDG-avid common iliac nodes, and 2 (5%) had direct spread to the aortocaval nodes. Three patients (7%) had FDG-avid aortocaval nodes above the IMA without FDG-avid nodes between the aortic bifurcation and IMA. All 3 of these patients also had FDG-avid nodes in the pelvis. Nineteen patients (45%) had FDG-avid nodes above and below the IMA, and 20 (48%) had FDG-avid nodes below the IMA only.ConclusionsThis hypothesis-generating study revealed that a small number of patients have PET-positive aortocaval nodes above the IMA only. For patients undergoing surgical staging for locally advanced cervical cancer, dissection to the renal vessels may be necessary. A future international, randomized study will prospectively evaluate the locations of pathologically positive aortocaval lymph nodes.

Individually customised parametrial boost for locally advanced cervical cancer: is 2D planned external beam radiotherapy useful?

2019 ◽  
Vol 19 (3) ◽  
pp. 248-253
Author(s):  
Aparna Gangopadhyay ◽  
Subrata Saha
Keyword(s):  
Cervical Cancer ◽  
External Beam Radiotherapy ◽  
Locally Advanced ◽  
Intracavitary Brachytherapy ◽  
External Beam ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Pelvic Wall ◽  
Significant Difference ◽  
Median Period

AbstractAim:Pelvic wall control and toxicity was retrospectively assessed in patients who received individually customised parametrial boost (PMB) for locally advanced cervical cancer with 2D planned external beam radiotherapy. Outcomes of a dose-escalated combined boost were also evaluated.Materials and methods:Toxicity and pelvic wall recurrence was evaluated over a median period of 24 months between two groups who received different pelvic wall doses. One group was randomised to receive either intracavitary brachytherapy (ICRT) with an external beam PMB using a customised midline shield, or a dose-escalated combined boost with interstitial brachytherapy (ISBT) and PMB. The comparator group received no PMB.Results:At 24 months, pelvic wall recurrence occurred in 2/112 and 40/130 with and without PMB, respectively (p < 0·000001). No significant difference in toxicity was noted between boost versus no-boost groups (p = 0·56). Combined ISBT/PMB dose escalation showed no significant difference in pelvic wall recurrence compared with PMB alone (p = 0·49).Findings:Individually customised 2D PMBs with 3D image-based ICRT was safe and improved pelvic wall control in locally advanced cervix cancer. Dose-escalated combined boosts offered no significant benefit over standard boost doses.

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