Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cervical Cance
Treatment: Proton Beam Therapy phase 1:33 fractions (treatment sessions) of Proton beam therapy image guided radiation therapy (IGRT)
The insurer denied: Proton Beam Therapy phase 1:33 fractions (treatment sessions) of Proton beam therapy image guided radiation therapy (IGRT)
The denial is overturned

The patient is an adult female with a history of cervical cancer. She is status post chemoradiotherapy with mediastinal and retroperitoneal nodal recurrence status post multiple courses of systemic therapy. Her disease is well controlled except for two oligometastatic lesions in her retroperitoneal and pelvic nodes. Definitive re-irradiation was recommended, and proton therapy was requested.

The requested Proton Beam Therapy phase 1:33 fractions (treatment sessions) of Proton beam therapy image guided radiation therapy (IGRT) is medically necessary.

Recurrent cervical cancer that requires repeat radiation is rare, and clinical data in the literature is limited. However, there are studies that show that proton therapy is superior in sparing the surrounding tissue compared to photon-based techniques.
A 2012 study compared 3D (three-dimensional), IMRT (intensity-modulated radiation therapy) and proton therapy techniques for retroperitoneal sarcomas. The bowel and kidney dose were significantly reduced with proton therapy compared to photon therapy and the authors concluded that "Based on Quantitative Analysis of Normal Tissue Effects in Clinic benchmarks, the dosimetric advantage of proton therapy may be less gastrointestinal and genitourinary toxicity."
Another 2018 study from Shinoto et al. evaluated 224 patients with locally recurrent rectal cancer patients treated with proton therapy. The OS (overall survival) rates were 73% (percent) at 3 years and 51% at 5 years. The LC (local control) rates were 93% at 3 years, and 88% at 5 years. Grade 3 acute toxicity was observed in only 3 three patients. The authors concluded that "This first multi-institutional analysis of C-ion [carbon-ion] RT [radiation therapy] for LRRC [locally recurrent rectal cancer] indicated relatively favorable outcomes with limited toxicities."
The patient is an adult female with a history of cervical cancer. She is status post chemoradiotherapy 8 years ago with mediastinal and retroperitoneal nodal recurrence status post multiple courses of systemic therapy. Her disease is well controlled except for two oligometastatic lesions in her retroperitoneal and pelvic nodes. Definitive re-irradiation was recommended, and proton therapy was requested. In order to provide a better chance of local control, additional radiation therapy is necessary. The total dose planned to provide adequate control is at least 50 Gy (gray), which is well above the 
tolerance dose of the surrounding critical structures such as the bowel, rectum, bladder and sacral plexus when the total dose is combined with her prior radiation. Because of the proximity to these structures, conventional radiation techniques can result in adverse radiation effects in this otherwise healthy woman. Other types of radiation therapy such as photon stereotactic body radiotherapy or IMRT (intensity-modulated radiation therapy) has also been used to treat the disease, however, because of the location, size and extent of the disease, they are not the optimal modalities for this patient. In this case, a proton/photon comparison plan was done, and the photon plan would result in excessive dose to the bowel and bilateral kidneys. Proton beam radiation therapy, therefore, is medically necessary for this patient at this time.