Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

Gandhi, Ajeet Kumar; Sharma, Daya Nand; Rath, G.K.; Julka, Pramod Kumar; Subramani, V.; Sharma, S.; Manigandan, D; Laviraj, M.A.; Kumar, Sunesh; Thulkar, Sanjay

doi:10.1016/j.ijrobp.2013.06.2059

Cited by 199 publications

(157 citation statements)

References 18 publications

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“…Multiple previous retrospective and prospective studies have found that the use of IMRT is associated with reduced normal tissue dose and toxicity compared with conventional radiation techniques (ie, either anteroposterior/posteroanterior or 4-field box methods) (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(26)(27)(28)(29). However, IMRT has not been widely tested in multicenter trials of cervical cancer, in particular, for the large international population of patients undergoing definitive CRT.…”

Section: Discussionmentioning

confidence: 99%

“…In contrast, intensity modulated radiation therapy (IMRT) uses multiple beam angles or arcs, along with sophisticated optimization algorithms, to generate dose distributions that conform to the target and reduce the dose to the surrounding tissues. Previous studies have found that IMRT reduces the dose to pelvic organs, maintains acceptable target coverage (10), and is associated with reduced toxicity and favorable outcomes in cervical cancer (11)(12)(13)(14)(15). In addition, modeling studies have indicated that optimized IMRT plans can decrease toxicity by approximately twofold (16)(17)(18)(19).…”

Section: Introductionmentioning

confidence: 99%

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Phase 2 Multicenter Clinical Trial of Bone Marrow–Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage IB-IVA Cervical Cancer

Mell

Sirák

et al. 2016

International Journal of Radiation Oncology*Biology*Physics

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SummaryWe performed an international phase II trial to test the Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) reduces acute hematologic and gastrointestinal (GI) toxicity for patients with locoregionally advanced cervical cancer. hypothesis that intensity modulated radiation therapy (IMRT) would reduce the acute toxicity for locoregionally advanced cervical cancer. For the 83 patients enrolled, acute gastrointestinal toxicity was significantly reduced with both IMRT and positron emission tomography-guided bone marrow sparing IMRT (IG-IMRT) compared with historical controls. The incidence of neutropenia was significantly reduced in patients who underwent IG-IMRT. We conclude that IMRT reduces acute toxicity compared with standard treatment in this population and that IG-IMRT warrants testing in randomized trials.Methods and Materials: We enrolled patients with stage IB-IVA cervical carcinoma in a single-arm phase II trial involving 8 centers internationally. All patients received weekly cisplatin concurrently with once-daily IMRT, followed by intracavitary brachytherapy, as indicated. The primary endpoint was the occurrence of either acute grade !3 neutropenia or clinically significant GI toxicity within 30 days of completing chemoradiation therapy. A preplanned subgroup analysis tested the hypothesis that positron emission tomography-based image-guided IMRT (IG-IMRT) would lower the risk of acute neutropenia. We also longitudinally assessed patients' changes in quality of life. Results: From October 2011 to April 2015, 83 patients met the eligibility criteria and initiated protocol therapy. The median follow-up was 26.0 months. The incidence of any primary event was 26.5% (95% confidence interval [CI] 18.2%-36.9%), significantly lower than the 40% incidence hypothesized a priori from historical data (PZ.012). The incidence of grade !3 neutropenia and clinically significant GI toxicity was 19.3% (95% CI 12.2%-29.0%) and 12.0% (95% CI 6.7%-20.8%), respectively. Compared with patients treated without IG-IMRT (nZ48), those treated with IG-IMRT (nZ35) had a significantly lower incidence of grade !3 neutropenia (8.6% vs 27.1%; 2-sided c 2 PZ.035) and nonsignificantly lower incidence of grade !3 leukopenia (25.7% vs 41.7%; PZ.13) and any grade !3 hematologic toxicity (31.4% vs 43.8%; PZ.25). Conclusions: IMRT reduces acute hematologic and GI toxicity compared with standard treatment, with promising therapeutic outcomes. Positron emission tomography IG-IMRT reduces the incidence of acute neutropenia. Ó

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Phase 2 Multicenter Clinical Trial of Bone Marrow–Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage IB-IVA Cervical Cancer

Mell

Sirák

et al. 2016

International Journal of Radiation Oncology*Biology*Physics

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“…Gandhi et al proved that in patients who undergo radiochemotherapy using the conventional technique, the post-radiation reaction in gastrtointestinal tract in the G ≥ 2 degree was present in 63.6% of the patients and in the IMRT technique in 31.8% the patients, the reaction in G ≥ 3 degree respectively in 27.3% and 4.5% pts. 25 Hui et al proved that for the bone marrow the values V10, 20, 30, 40, 50, 30, 40, 50 are more advantageous in IMRT technique compared to 3D technique, which is also related to the decrease of hematological complications. 26 Similarly, Simpson et al proved such a dependency for the volume of intestine receiving the dose above 45Gy and the intensification of post radiation reaction.…”

Section: Discussion Of Resultsmentioning

confidence: 99%

Tolerance of combined radiochemotherapy in cervical cancer patients

Izmajłowicz¹,

Rusiecka²,

Sztuder³

et al. 2017

Adv Clin Exp Med

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Background. Radiochemotherapy in cervical cancer was implemented to clinical practice based on 5 randomized clinical trials, published at the end of the 20 th century, which showed improvement in the total and symptomless survivals by about 10-18%. The increase of therapeutic index of such treatment can take place only when the efficiency of the treatment outweighs the increase of its toxicity. Thus, it is necessary to monitor treatment reaction during radiochemotherapy.

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“…24,25 There are several reports regarding pelvic irradiation in the radical setting with an intact prostate [26][27][28] or comparing pelvic IMRT with pelvic 3DCRT. [29][30][31][32] In radical series, the majority of the retrospective analyses showed some increase in acute toxicity (principally GI rather than GU) with pelvic radiotherapy. 26,33 Some studies, however, did not show any statistically significant increase in toxicity in patients treated to the pelvis.…”

Section: Discussionmentioning

confidence: 99%

No increase in toxicity of pelvic irradiation when intensity modulation is employed: clinical and dosimetric data of 208 patients treated with post-prostatectomy radiotherapy

Jereczek‐Fossa

Ciardo

Ferrario

et al. 2016

BJR

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Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

Cited by 199 publications

References 18 publications

Phase 2 Multicenter Clinical Trial of Bone Marrow–Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage IB-IVA Cervical Cancer

Phase 2 Multicenter Clinical Trial of Bone Marrow–Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage IB-IVA Cervical Cancer

Tolerance of combined radiochemotherapy in cervical cancer patients

No increase in toxicity of pelvic irradiation when intensity modulation is employed: clinical and dosimetric data of 208 patients treated with post-prostatectomy radiotherapy

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