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Evaluation of Neutron Irradiation of Pancreatic Cancer

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Evaluation of Neutron Irradiation of Pancreatic Cancer 1- I anhdd (CW1214): 283-289. 1969. Evaluation of Neutron Irradiation of Pancreatic Cancer Results of a Randomized Radiation Therapy Oncology Group Clinical Trial Frank J. Thomas,M.D., John Krall, Ph.D., Frank Hendrickson, M.D., Thomas w.Griffin, M.D., Jerrold P. Saxton, M.D., -RobertG. Parker, M.D., and Lawrence W. Davis, M.D. Baween 1980-84, the Radiation Therapy Oncology Group Carcinoma of the pancreas annually accounts for conducted a trial in patients with untreated, unrrsectable 10- over 24,000 deaths per year in the United States, where carcinomas of the pancreas. Patients were randomly alized it is the leading cause of cancer deaths (I). Only chosen to rcaive either 6,400 cGy with photons, the cquiv- fifth dent dose with a combination of photons and neutrons about 10-1546 of patients are candidates for radical (mixed-beam irradiation), or neutrons alone. A total of 49 excision (2), and even among these patients, the 5-year cases were evaluable, of which 23 wen treated with photons, crude survival rate is 1546, ‘with local recurrences in up 1 I with mixed-beam therapy, and 15 with neutrons alone. to 50% (3). Overall, the prognosis is poor, with only The median survival time was 5.6 months with neutrons, 7.8 months with mixed-beam radiation, and 8.3 months with 3-5% surviving 5 years (I). photons. The median local control time was 6.7 months with For the casc that is medically or technically inop neutrons, 6.5 months with mixed-beam radiation, and 2.6 erable, radiation can palliate the local symptoms of months with photons. These differences are not statistically advanced disease with relatively low doses of 3,000- significant. Evidence of moderate-to-life-thrnin~ gas- 4,000 cGy (4). With higher doses of 5,000-6,500 cGy trointestinal or hepatic injury was present in three patients (with or without chemotherapy), the symptom-free in- treated with neutrons and one patient treated with photons. The causes of this apparent difference are discussed. This terval is extended (3,and the median survival time is study demonstrates there is no evidence to suggest that neu- typically 7-13 months (1.5-8). At the time of death, tron irradiation, either alone or in combination with photon locally persistent disease is frequently Seen (9,lO). Thus, irradiation, produces better local control or survival rates improvement in the local control rate should improve than photon irradiation. the overall survival rate in patients with this disease. Key Words: Mixed-beam radiation-Neutron therapy- Pancreatic cancer-Photon therapy. As an alternative to increasing the physical dose, high linear energy transfer (LET) radiation attempts to deliver a biologically more effective dose and thus OOlb303 improve the therapeutic ratio. The potential advantage From the Department of Radiation Oncology, Cleveland Clinic of neutron therapy is a reflection of the biological con- Foundation, Cleveland, Ohio (FJ.T.,J.P.S.); the Dividon of Statistics. sequences of high LET in tissue (1 1). The dense ion- Radiation Therapy Oncology Group. Philadelphia Pennsylvania ’K);the Neutron Therapy Department Femi National Acalerator ization produced by neutrons leads to more effective bratory. Batavia, Illinois (F.H.); the Department of Radiation killing of cells protected by virtue of hypoxia. The ox- .icology, University of Washington Hospital. Seattle. Washington ygen enhancement ratio with neutrons is ap (T.W.G.);the Department of Radiation Oncology. University of Cal- (OER) ifornia-los Angela, ksAngeles. California (R.G.P.):and the De- proximately I .6, compared to an OER of 2.5-3.0 with partment of Radiation Therapy. Albert Einstein Medical College, high-energy photons. The repair of both sublethal and Montcfiore Medical Center, Bronx. New York (L.W.D.). potentially lethal damage is diminished with high Address correspondence and reprint requests to Dr. F. J. Thomas. LET Case Western University School of Medicine. 2074 Abington Road. radiation as compared to photon radiation. Finally, Cleveland, OH 44 106. U.S.A. there is less variation in radiation wmitivitv as a fiinc- 284 F. 1. THOMAS ET AL. tion of cell cycle position with neutrons. In clinical Treatment plans were designed to deliver doses t practice, these potential advantages of neutron ther- equivalent to 6,400 cGy at 180-200 cGy per fraction c€ apy have been demonstrated in the treatment of ad- to the tumor volume in the photon or mixed-beam D enocarcinomas of the prestate (12.13) and salivary arms but not to exceed 5,000 &y to the bowel outside ai slaad (14). the target volume, 2,000 d3y to the kidneys, 4,000 This study (Radiation Therapy Oncology Gfoup, or cGyto the spinal cord, or 3,500 cGy to the liver. When P; RTOG, 79-21) was designed to detedne whether patients were randomly assigned to dveneutrons r; neutron radiation alone or combined with conven- alone, the Same equivalent doses were employed, but I< tional photon radiation (mixed-beam radiation) was the treatment was delivered in IS fkidons over 7 ii superior to conventional photon irradiation in the weeks. The target volume was specified as coveringthe n treatment of lacally advanced pancreatic adenocarci- gross disease with a 2cm margin. The recommended n nomas. left lateral margin was 3 cm to encompass a greater ! H volume of the pancreas, as pancreatic cancers may i tl spread along the pancreas in an occult After f; MATERIAIS AND METHODS fashion. I the equivalent of 4,500 cGy, the fields could be reduced f! Forty-nine patients were entered in this study be- to a margin of 1-2 cm around the gross disease. i' C tween February 1980 and October 1984. Mandatory i premndomization evaluation included a complete his- patient i ta TABLE 1. characteristics ! tory and physical examination, laparotomy with biopsy ! L and marking of the gross tumor margins and biliary Therapy. no. of Pa- ! t r or gastrointestinal bypass procedures when indicated, Photons Neutrorrr Mixedbeam chest roentgenogram, upper gastrointestinal series, i.v. '! Total no. ocpatiec~ts 23 15 11 pyelogram, computed tomography scan, complete I blood count, and blood chemistry studies including Sex i male 14 6 5 i carcinoembryonic antigen, alkaline phosphatase, blood female 9 9 6 urea nitrogen, and blood glucose level determinations. 4 Histology I To be eligible for randomization, patients had to be 23 14 9 I ambulatory and, although locally advanced, tumors isbetcel- 0 1 2 I had to be limited to a target volume no greater than Mececltiation 1,700 well 5 4 2 cm'. Patients were excluded from this study if I they had a prior malignancy except skin cancer, unless moderate 11 6 5 poor 4 3 4 they had been disease free for 5 years; prior chemo- unknown 3 2 0 therapy or radiation therapy; chronic renal disease; Location overt metastases; or acute intercurrent postoperative head 16 10 4 complications that would preclude radiation. body 1 1 1 The study contained three treatment arms (photons, tail 0 1 0 body and tad 1 1 1 neutrons, and mixed-beam irradiation). Facilities par- -andbody 5 1 5 ticipating in this study (Fermilab, the Cleveland Clinic diffuse 0 1 0 Foundation, and the University of Washington) could Kamofsky value -70 4 1 3 elect to randomly assign patients to either two or three 80-90 14 14 6 of the treatment arms but were required to participate 100 5 0 2 in the photon control arm. Fermilab chose neutrons Tunor size, cm2 alone, while the Cleveland Clinic and the University 1-40 15 10 8 of Washington chose mixed beam. Patients were ran- 41-80 6 3 3 80-160 1 1 0 domly assigned through the RTOG operational ofice unknown 1 1 0 to receive either photon (control) radiation therapy, neutrons, or mixed-beam radiation therapy. Neutron 0 0 1 doses were scaled according to the relative biologic ef- 7 4 2 fectiveness calculations for the various institu- 4 3 4 (RBE) 12 8 4 tions: 3.3 for the University of Washington and the Cleveland Clinic Foundation and 3.0 for Fennilab. The 8 9 6 i gamma contaminate was included in the neutron dose. 9 4 3 Mixed-beam irradiation is a mixture of 40% neutrons 2 0 1 and 60% photons. 4 2 1 Am J <%n Onrvl (CC'l). t'id 12. No 4. IY80 001b3011 i NEUTRON IRRADIATION OF PANCREATIC CANCER 285 The quality of the radiotheraw was ensured by a antral review of localization films and munent plans Data were reviewed at a central office by data managers The majox end points of this study are local/eonal and the study chairman. control, survival, and &-free survival rates. Com- The efficacy of the treatment was evaluated by com- plication rates and tolerance of the inadiated tissue are paring the duration of local control, the overall survival secondary end points. rate, and the disease-free survival rate. In each instance, Table 1 shows that, of the major patient character- Kaplan-Meier plots were generated and compared us- istics, there were no significant differences in the dis- ing the Mantel-Haenszel test. The survival rate was tribution of pretreatment factors among the three measured as absolute survival from the start of treat- treatment groups. ment. For the evaluation of local control. patients in Figure 1 shows the fractional survival rate by treat- whom there was a persistence of disease at the time of ment arm as a function of time. The median survival tbe fix% follow-up visit were considered to have local duration of the entire group (n = 49) is 7.1 months, failures from day 1.
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