Appropriate Use of Radiation Therapy
Selected Abstracts
 

ADRENAL METASTASES
 
Palliative radiotherapy for symptomatic adrenal metastases.
Soffen EM, Solin LJ, Rubenstein JH, Hanks GE,         Cancer 1990 Mar 15;65(6):1318-1320
Ten of 16 patients were treated with 3000 cGy to opposed anterior and posterior fields (300-cGy fractions [four patients] and 250-cGy fractions [six patients]). The remaining six patients were treated with a variety of techniques, with total doses ranging from 2925 cGy to 4500 cGy. The patients were analyzed for response at their first follow-up visit (2 to 4 weeks after treatment). The overall response rate was 75% (12 of 16 patients). Six patients (38%) had complete pain relief without medication that lasted until death. Two patients had marked pain relief, but still required analgesics. Four patients had marked or moderate pain relief that did not continue through follow-up. Four patients had minimal to no response. All patients were observed until death, with a median survival time after irradiation of 3 months (range, 0.5 to 11 months).

Radiation therapy for adrenal metastases
Soejima T, Hirota S, Hishikawa Y, Hamanaka A, Ozawa Z, Endo M, Kojima Y, Kozuma K, Suzuki Y, Obayashi K, Takada Y           Nippon Igaku Hoshasen Gakkai Zasshi 1997 Oct;57(12):801-804
Fourteen patients, 13 with primary lung carcinoma and one with primary unknown carcinoma, received radiation therapy for adrenal metastases from 1984 to 1995. Total dose ranged from 16 Gy to 60 Gy, and fractional dose from 1.6 Gy/ Fr to 3 Gy/Fr. RESULTS: Partial response of the local tumor was recognized in 2 of 7 patients by CT imaging. Pain relief was obtained in 7 of 8 patients. Median survival was 3 months, and 6-month survival was 28.6% in all patients. CONCLUSION: Radiation therapy is useful for the purpose of pain relief in adrenal metastases.
 
BONE METASTASES

The palliation of symptomatic osseous metastases: final results of the Study by the Radiation Therapy Oncology Group.
Tong D, Gillick L, Hendrickson FR         Cancer 1982 Sep 1;50(5):893-899
 Ninety percent of patients experienced some relief of pain and 54% achieved eventual complete pain relief. Important prognosticators included the initial pain score and the site of the primary lesions. Administration of steroid or chemotherapy during the one-month on-study period did not influence the frequency of pain relief. The low-dose, short-course schedules were as effective as the high-dose protracted programs.

Reanalysis of the RTOG study of the palliation of symptomatic osseous metastasis.
Blitzer PH       Cancer 1985 Apr 1;55(7):1468-1472
This is a reanalysis of the data from the Radiation Therapy Oncology Group (RTOG) study of the palliation of metastasis to bone. The RTOG multicenter clinical trial studied pain relief in 759 patients randomly assigned to a variety of dose-fractionation schedules: 270 cGy X 15 fractions, 300 X 10, 300 X 5,400 X 5, and 500 X 5. The multivariate statistical technique of logistic regression was used. The results differed from a previous report in that number of fractions was statistically significantly related to complete combined relief (that is, absence of pain and cessation of the use of narcotics).  The conclusion is that protracted dose-fractionation schedules are more effective than short course schedules.
 
 Single-dose half-body irradiation for palliation of multiple bone metastases from solid tumors. Final Radiation Therapy Oncology Group report.
Salazar OM, Rubin P, Hendrickson FR, Komaki R, Poulter C, Newall J, Asbell SO, Mohiuddin M, Van Ess J
Cancer 1986 Jul 1;58(1):29-36
This is the final analysis of Protocol #78-10 which explored increasing single-doses of half-body irradiation (HBI) in patients with multiple (symptomatic) osseous metastases. When given as palliation, HBI was found to relieve pain in 73% of the patients. In 20% of the patients the pain relief was complete; over two thirds of all patients achieved better than 50% pain relief. The HBI pain relief was dramatic with nearly 50% of all responding patients doing so within 48 hours and 80% within one week from HBI treatment. Furthermore, the pain relief was long-lasting and continued without need of retreatment for at least 50% of the remaining patient's life. These results compare favorably with those obtained by the Radiation Therapy Oncology Group (RTOG) using several conventional daily fractionated schemes on similar patients in a prior study (RTOG #74-02). HBI achieves pain relief sooner and with less evidence of pain recurrence in the irradiated area than conventionally treated patients. The most effective and safest of the HBI doses tested were 600 rad for the upper HBI and 800 rad for the lower or mid-HBI. There were excellent responses found in practically all tumors treated, but especially breast and prostate among which over 80% of all patients experienced pain relief, 30% in a complete fashion. Single-dose HBI emerges as one of the safest, fastest, and more effective palliative tools for intractable cancer pain in modern radiation oncology.
 
Fractionated half-body irradiation for pain palliation in widely metastatic cancers: comparison with single dose.
Salazar OM, DaMotta NW, Bridgman SM, Cardiges NM, Slawson RG, Int J Radiat Oncol Biol Phys 1996 Aug 1;36(1):49-60
PURPOSE: To explore fractionated half-body irradiation (HBI) for pain palliation and determine if it is more efficient and effective than single dose The HBI fields were 28% upper, 25% mid, and 47% lower; three patients had both upper and lower HBI. An initial performance status (PS) 3&4 with a life expectancy < 3 months was found in 50% of patients. The HBI techniques used on consecutive patients were: single dose (SD) in 54% with escalating doses of 4-10 Gy; split-course (SC) in 12% with two 4 Gy single doses separated by 2 weeks; and daily fractionated (DF) in 34% with five fractions of 3 Gy each. There were 68 of 75 HBI (91%) given for pain control purposes. RESULTS: The percent total (complete) pain relief was SD-73(32), SC-50(13), and DF-96(49). Time to maximum and (complete) relief was: SD 5 days each and DF HBI 7(11) days. Pain-free survival (PFS) was short but so was overall survival (OS). PFS was SD-5, SC-4.5, and DF-19 weeks. The percent of the remaining patient's life spent pain free without retreatment (NPR) was SD-38, SC-34, and DF-68. Differences in pain relief, PFS, OS, and NPR were significant and carried over primary tumor types; prostate, breast, and surprisingly GI were very responsive (90, 84, and 83%, respectively).  Despite lack of premedication in DF-HBI, toxic reactions were identical to SD-HBI with premedication. CONCLUSION: HBI is still the most effective and efficient way to palliate pain from widely disseminated cancer. Fractionating HBI eliminates need for the premedication and close patient monitoring required for SD-HBI. It also allows for an increase in total dose which can produce better responses in pain relief, duration of relief, PFS, OS, and quality of life.
 
 Strontium-89--precursor targeted therapy for pain relief of blastic metastatic disease.
Robinson RG      Cancer 1993 Dec 1;72(11 Suppl):3433-3435
Strontium-89 is a radioactive calcium analog that provides an energetic beta particle for radiation therapy of osteoblastic disease. Strontium-89 is used as palliative therapy with the primary goal being pain relief. More than 500 patients with painful blastic metastatic disease were treated at University of Kansas Medical Center  Improvement (decrease in pain, increase in physical activity level) was noted in 80% of patients with prostate carcinoma and 81% of patients with metastatic breast cancer to bone. Marrow toxicity levels were acceptable. The therapy can be repeated at 3-month intervals. Strontium-89 is a safe and effective systemic therapy for painful blastic metastatic disease. There is no longer any reason why the vast majority of persons with painful blastic metastatic disease should continue to hurt.
 
BRAIN METASTASES
 
An overview of radiotherapy trials for the treatment of brain metastases.
Berk L   Oncology (Huntingt) 1995 Nov;9(11):1205-1212
Critical analysis of relevant randomized trials indicated that radiation therapy can effectively palliate the symptoms of brain metastases. Prognostic factors for improved survival are good performance status and the absence of a non-central nervous system tumor. The most efficient treatment protocol is controversial, but the literature supports the use of 20 Gy in five fractions for the treatment of patients with a poor prognosis. Patients with a solitary brain metastasis and no systemic disease benefit from resection of the brain metastasis followed by postoperative radiation.
 
Radiotherapy for cerebral metastases.
Sneed PK, Larson DA, Wara WM     Neurosurg Clin N Am 1996 Jul;7(3):505-515
Whole brain radiotherapy (WBRT) for patients with unresected brain metastases results in symptomatic response in about 50% of patients and improvement in median survival to 3 to 6 months. Most patients with brain metastases are appropriately treated with a conventional palliative course of 30 Gy in 10 fractions over 2 weeks, although accelerated hyperfractionation with 32 Gy to the whole brain plus a boost to at least 54.4 Gy at 1.6 Gy twice daily yields better results for patients with solitary metastases. Patients with a life-expectancy of greater than 6 months should receive at most that or equal to 2.0 Gy per fraction to minimize the risk of radiation-induced leukoencephalopathy and dementia. Patients with good performance status, absent or controlled primary tumor, and no extracranial metastases might benefit from surgical resection or radiosurgery (with or without adjunctive WBRT) to improve local control.
   
A randomized phase III study of accelerated hyperfractionation versus standard in patients with unresected brain metastases: a report of the Radiation Therapy Oncology Group (RTOG) 9104.
Murray KJ, Scott C, Greenberg HM, Emami B, Seider M, Vora NL, Olson C, Whitton A, Movsas B, Curran W  Int J Radiat Oncol Biol Phys 1997 Oct 1;39(3):571-574
PURPOSE: To compare 1-year survival and acute toxicity rates between an accelerated hyperfractionated (AH) radiotherapy (1.6 Gy b.i.d.) to a total dose of 54.4 Gy vs. an accelerated fractionation (AF) of 30 Gy in 10 daily fractions in patients with unresected brain metastasis. Of the 429 eligible and analyzable patients, the median survival time was 4.5 months in both arms. The 1-year survival rate was 19% in the AF arm vs. 16% in the AH arm. No difference in median or 1-year survival was observed among patients with solitary metastasis between treatment arms.  This randomized comparison could not demonstrate any improvement in survival when compared to a conventional regimen of 30 Gy in 10 fractions. Therefore, this accelerated hyperfractionated regimen to 54.4 Gy cannot be recommended for patients with intracranial metastatic disease.

Analysis of outcome in patients reirradiated for brain metastases.
Wong WW, Schild SE, Sawyer TE, Shaw EG    Int J Radiat Oncol Biol Phys 1996 Feb 1;34(3):585-590
This retrospective study examines our experience with reirradiation of patients for progressive brain metastases after an initial+ course of WBRT. The median dose of the first course of irradiation was 30 Gy (range: 1.5-50.6 Gy). The median dose of the second course of irradiation was 20 Gy (range: 8.0-30.6 Gy). RESULTS: Twenty-three patients (27%) had resolution of neurologic symptoms, 37 patients (43%) had partial improvement of neurologic symptoms, and 25 patients (29%) had either no change or worsened after reirradiation. The median survival following reirradiation was 4 months (range: 0.25-72 months). The majority of patients had no significant toxicity secondary to reirradiation. Reirradiation should be offered to patients who develop progressive brain metastases.
 
HEPATIC METASTASES

A comparison of misonidazole sensitized radiation therapy to radiation therapy alone for the palliation of hepatic metastases: results of a Radiation Therapy Oncology Group randomized prospective trial.
Leibel SA, Pajak TF, Massullo V, Order SE, Komaki RU, Chang CH, Wasserman TH, Phillips TL, Lipshutz J, Durbin LM, nt J Radiat Oncol Biol Phys 1987 Jul;13(7):1057-1064
Two hundred fourteen patients were accessioned to this study of whom 187 were evaluable. Radiation therapy was delivered to the whole liver to a dose of 21.0 Gy in 7 fractions. The addition of misonidazole did not significantly improve the therapeutic response to radiation therapy in any of the parameters studied. Hepatic irradiation was effective in relieving abdominal pain with 80% of the symptomatic patients achieving improvement following therapy. Pain was completely relieved in 54% of these patients. Palliation of pain was prompt, occurring within a median of 1.7 weeks from the initiation of treatment, and 94% of patients who improved did so within 6 weeks of treatment. The median duration of response was 13.0 weeks in the symptomatic patients; 52% of those surviving 3 months remained improved. KPS improved in 28% of patients. Serial CT scans revealed a partial response in 7% and a marginal response in 13% of patients. One patient had a complete response to treatment. The median survival of patients treated in this series was 4.2 months  There was no significant treatment related morbidity. Radiation therapy remains an excellent palliative tool for the management of patients with symptomatic hepatic metastases. Further research must continue to identify new methods of selectivity enhancing the tumor response to radiation therapy.

LUNG CANCER

Palliative radiotherapy for inoperable carcinoma of the lung: final report of a RTOG multi-institutional trial.
Simpson JR, Francis ME, Perez-Tamayo R, Marks RD, Rao DV, Int J Radiat Oncol Biol Phys 1985 Apr;11(4):751-758
Between June 1973 and February 1979,
409 patients with inoperable advanced non-oat cell carcinoma of the lung were randomized on RTOG protocol 73-02. Three treatment arms were evaluated: 40 Gy split course, 30 Gy continuous course, and 40 Gy continuous course. Patients were also randomized to receive cytoxan or no further therapy following irradiation. Three hundred sixteen patients were evaluable. Palliation of symptoms was achieved in 60% with 1/4 of the patients becoming symptom-free. Complete regression of local and regional tumor was produced in 15% and partial regression in 26%. There is no significant difference between the treatment arms in these objective response rates. Median survival times were approximately 6 months. Significant toxicity occurred in fewer than 6% of patients.
 

A randomized study on palliative radiation therapy for inoperable non small cell carcinoma of the lung.
Teo P, Tai TH, Choy D, Tsui KH, Int J Radiat Oncol Biol Phys 1988 May;14(5):867-871
Between October 1981 and November 1984, 291 patients with inoperable advanced non-small cell carcinoma of the lung (NSCLC) were randomized to a two-arm study. Without correction for lung attenuation 45 Gy/18 fractions/4 1/2 weeks were given in arm 1 and 31.2 Gy/4 fractions/4 weeks were given in arm 2. Prognosis was poor with an overall median survival of 20 weeks and was similar in both arms. Radiological tumor response was also similar: 53% in arm 1 and 50% in arm 2. However arm 1 was superior than arm 2 in achieving symptom palliation, 71% vs 54%, p less than 0.02. Treatment complications were mild and included mainly radiation oesophagitis and pneumonitis and pulmonary fibrosis. Treatments in both arms were equally well tolerated.
 
 
 
 PELVIC CANCERS
 

Palliative radiotherapy for ovarian cancer.
Adelson MD, Wharton JT, Delclos L, Copeland L, Gershenson D, Int J Radiat Oncol Biol Phys 1987 Jan;13(1):17-21
Large single-fraction irradiation is effective palliation for advanced ovarian cancer. It has an acceptable complication rate and requires only a limited number of visits (i.e., one treatment per 4-week course) to administer. Forty-two patients received single or multiple fractions of (three maximum) 10 Gray (Gy) to the pelvis.  Forty patients had received preirradiation chemotherapy. Tumor size before and after radiotherapy was evaluable in 34 patients and decreased in 25. Bleeding decreased or stopped in 15 of 21 patients, and pain lessened or ceased in 11 of 20 patients. Thirteen patients had surgical procedures performed after irradiation therapy. Ten had gastrointestinal procedures, and in six radiation injury was believed to be the main contributor to complication. Hemorrhagic cystitis or proctitis occurred 6 to 18 months after irradiation in four patients. Three of these four patients received three 10 Gy fractions. The safest and most efficient dose may be one or two fractions, since three 10 Gy fractions may not increase palliation.
 

Palliation of advanced pelvic malignant disease with large fraction pelvic radiation and misonidazole: final report of RTOG phase I/II study.
Spanos WJ Jr, Wasserman T, Meoz R, Sala J, Kong J, Stetz J, nt J Radiat Oncol Biol Phys 1987 Oct;13(10):1479-1482
Between October 1979 and June 1982 forty-six patients were entered on a non-randomized Phase I-II protocol for the evaluation of Misonidazole combined with high dose per fraction radiation for the treatment of advanced pelvic malignancies. Pelvic radiation consisted of 1000 cGy in one fraction repeated at 4-week intervals for a total of three treatments.  The distribution of histology consisted of 20 gynecologic, 24 bowel, and 2 prostate malignancies. Of the thirty-seven patients completing the three treatments; there were 6 complete responses (14% CR), 10 partial responses (27% PR) 19 minimal or no response (32% NR), and 4 unevaluable. One patient remains NED 5.5 years following radiation. Radiation toxicity was significant for late bowel damage. There were 4 (11%) Grade 3 and 7 (19%) Grade 4 gastro-intestinal (GI) toxicities. Because of the GI complication rate, this protocol for palliation of advanced pelvic malignancies has been replaced by a protocol that uses 4 fractions over 2 days (b.i.d.) of 370 cGy per fraction repeated at 3-week intervals for a total of 3 courses.

Late effect of multiple daily fraction palliation schedule for advanced pelvic malignancies (RTOG 8502).
Spanos WJ Jr, Clery M, Perez CA, Grigsby PW, Doggett RL, Poulter CA, Steinfeld AD, Int J Radiat Oncol Biol Phys 1994 Jul 30;29(5):961-967
Prospective evaluation of a palliative radiation schedule for advanced pelvic malignancies was conducted from 1985 to 1989 by RTOG 8502. The dose was 44.40 Gy in 12 fractions (3.7 Gy BID) with a rest after 14.80 Gy and 29.60 Gy. The pilot part of the study allowed for a variable rest interval of 3-6 weeks. The rest interval was then randomized between 2 and 4 weeks to determine effect on tumor control. No difference in tumor control was identified The crude late complications rate is 6%. Actuarial analysis using cumulative incidence shows 6.9% by 18 months. This represents a significant decrease in late complications from 49% seen with higher dose per fraction (10 Gy x 3) piloted by Radiation Therapy Oncology Group (7905) for a similar group of patients. Long-term analysis of late complication indicates this schedule can be used in the pelvis with relatively low incidence of complication. This schedule has significant logistic benefits and has been shown to produce good tumor regression and excellent palliation of symptoms.
 
Radiation palliation of cervical cancer.
Spanos WJ Jr, Pajak TJ, Emami B, Rubin P, Cooper JS, Russell AH, Cox JD, J Natl Cancer Inst Monogr 1996;21:127-130
Two radiation schedules have been reported on for the treatment of advanced pelvic disease including cervical cancer. The large single-dose schedule consisted of 10-Gy fractions repeated at monthly intervals to a maximum of 30 Gy. This schedule has produced good palliative results with symptomatic improvement in approximately 50% of patients and objective response in 35%-80%. However, severe late toxicity was shown to be as high as 42% (actuarial). The second schedule tested by the Radiation Therapy Oncology Group consisted of 3.7-Gy fractions given twice a day for 2 days (14.8 Gy) repeated after 2-4 weeks for a maximum of 44.4 Gy. There were 284 patients accrued, and the subgroup of 61 cervical cancer patients is analyzed in this article. The subjective response (50%-100% complete response) and objective response (53%) were similar to those observed with the large single-fraction schedule. The late toxicity was significantly lower (7%-actuarial). For patients who may survive 6 months or longer, this second schedule is preferable.
 
 

Phase II study of multiple daily fractionations in the palliation of advanced pelvic malignancies: preliminary report of RTOG 8502.
Spanos W Jr, Guse C, Perez C, Grigsby P, Doggett RL, Poulter C, Int J Radiat Oncol Biol Phys 1989 Sep;17(3):659-661
This Phase II protocol was designed around the format of a previously reported study for the palliation of advanced pelvic malignancies (RTOG 7905). The large dose per fraction (1000 cGy) of the first study unexpectedly demonstrated frequent late gastrointestinal toxicity and was replaced in the present study by 2 days of twice daily fractionation (370 cGy/fraction totaling 1480 cGy/course) based on linear quadratic consideration of acute and late toxicities. The interval between courses of 4 weeks was retained and the total dose for three courses was 4440 cGy. A total of 152 patients were entered of which 142 have sufficient follow-up information for analysis. Fifty-nine percent of the patients completed all three courses, 20% completed two courses, and 20% received only one course. The primary sites were: gynecological (39.4%); colorectal (32.4%); genitourinary (24.7%); and other (2.8%). The best overall response was: complete remission (10%); partial remission (22%); no change (24%); progression (10%); and unknown (27%). For the patients completing all three courses, the response was: complete remission (14%); partial remission (31%); no change (40%); progression (7%); and unknown (8%). Median survival was 4.5 months and the actuarial survival at 12 months is 19%.
 

Palliative reirradiation for recurrent rectal cancer.
Lingareddy V, Ahmad NR, Mohiuddin M, Int J Radiat Oncol Biol Phys 1997 Jul 1;38(4):785-790
PURPOSE: The purpose of this study was to analyze the efficacy and acute and late toxicity of reirradiation for recurrent rectal cancer. . Median initial RT dose to the pelvis was 50.4 Gy. Median reirradiation dose was 30.6 Gy. The RTOG Grade 3 acute toxicity rate was 31%. The RTOG Grade 3 and 4 late toxicity rates were 23 and 10%, respectively. On multivariate analysis, the only factor associated with reduced late toxicity was hyperfractionated delivery of reirradiation. Bleeding, pain, and mass effect were palliated completely in 100, 65, and 24% of instances, respectively, and the majority of responding patients were palliated until death. The overall median survival time from retreatment was 12 months. The 2- and 3-year overall actuarial survival rates were 25 and 14%, respectively.