Comparison of helium-ion radiation therapy and split-course megavoltage irradiation for unresectable adenocarcinoma of the pancreas. Final report of a Northern California Oncology Group randomized prospective clinical trial.

Abstract

Forty-nine patients with locally advanced carcinoma of the pancreas were treated in a randomized, prospective study comparing definitive helium ion radiation therapy with conventional split-course megavoltage photon irradiation. Patients in each treatment arm underwent exploratory staging laparotomy followed by concurrent radiation therapy and 5-fluorouracil chemotherapy. Patients treated with photons received 6,000 cGy over a period of 10 weeks; patients treated with helium irradiation received a 6,000-7,000-cGy-equivalent dose over a period of 8-9 weeks. There was no significant difference in overall survival between patients in the two treatment arms (P = .29). Patients treated with helium ions had a slightly longer median survival (7.8 months) than the photon-treated patients (6.5 months). Local control rates were slightly higher in the helium-treated patients (10% vs 5%). Complications included one chemotherapy-related death. Four of the five helium-treated patients who survived longer than 18 months died of local failure without distant metastases. These results suggest that more aggressive local therapy could result in improved survival in helium-treated patients.

Review of clinical experience with ion beam radiotherapy

“…Early data from the University of California, Berkeley, comparing helium and photon irradiation in 49 patients reported superior LC rates for helium therapy, although increased LC did not translate into increased survival in this cohort [66]. Although the protocol applied combined chemoradiation, the treatment regimen consisted of a split-course radiation treatment, which would not be state of the art today.…”

“…Further dose escalation, by the application of particle therapy, has been investigated in a number of studies. Kato and co-workers published two Phase I-II trials (involving 44 and 94 patients, respectively) on the treatment with carbon ions [66][67][68]. All patients were diagnosed with locally advanced carcinoma of the cervix (median diameter 6.5 cm).…”

“…The physical properties of particle beams, which allow sharp dose gradients and hence relative dose escalation and minimised dose to normal organs, seemed especially appealing for the treatment of otherwise relatively radio-resistant tumours. Early data from institutions in the USA, such as the Lawrence Berkeley National Laboratory, seemed to clinically support this physical advantage [1][2][3][4]. However, this vision had to be pursued for quite some time before the pilot project for heavy-ion treatment was finally born.…”

Particle therapy tumour outcomes: An updated systematic review

“…23 The other compared PBT to transarterial chemoembolisation (TACE). 22 The reference list of the Lodge et al 20 and De Ruysscher et al 19 systematic reviews identified that only four of the combined 106 studies were RCTs, [24][25][26][27] with the rest mostly level IV evidence through retrospective Once repeated studies between systematic reviews were removed, nine RCTs remained. Only one of these compared PT to photon therapy in the context of prostate cancer dose escalation 25 using older (passive scattering) treatment delivery techniques and underdeveloped image guidance, the remaining were pure dose fractionation comparison studies, [28][29][30][31] examined Helium ion therapy 24,26 or compared PT to another form of treatment such as TACE 22 or transpupillary thermotherapy.…”

Randomized trials in exocrine pancreatic cancer

“…Mimo znacznej liczby [119][120][121][122][123][124][125][126] dobrze zaplanowanych badań w małych grupach chorych przeprowadzanych w ciągu 30 lat rola radioterapii z zastosowaniem cytostatyków lub bez ich zastosowania nie została wystarczająco potwierdzona. Należy przypuszczać, że gdyby radioterapia miała istotne znaczenie w terapii raka trzustki, do tej pory znaleziono by na to dowody.…”