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(Radiology. 2001;218:452-456.)
© RSNA, 2001

Radiation Oncology

Intracranial Germinoma: Radiation Therapy with Tumor Volume-based Dose Selection1

Yuta Shibamoto, MD, DMSc, Keisuke Sasai, MD, DMSc, Natsuo Oya, MD, DMSc and Masahiro Hiraoka, MD, DMSc

1 From the Departments of Oncology, Institute for Frontier Medical Sciences (Y.S.), and Therapeutic Radiology and Oncology (K.S., N.O., M.H.), Kyoto University, Sakyo-ku, Kyoto 606-8507, Japan. From the 1999 RSNA scientific assembly. Received November 30, 1999; revision requested December 30; final revision received April 3, 2000; accepted May 1. Supported in part by the Grant-in-Aid for Scientific Research (B) from the Japanese Ministry of Education, Science and Culture (10557087, 07455339, 11877152). Address correspondence to Y.S. (e-mail: yuta@frontier.kyoto-u.ac.jp).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
PURPOSE: To prospectively investigate whether intracranial germinomas, except large ones, can be cured with radiation doses lower than 50 Gy and to determine 10-year follow-up results.

MATERIALS AND METHODS: Between 1985 and 1995, 38 patients with intracranial germinoma diagnosed histologically or with established criteria were enrolled. Total radiation doses to the primary tumor site were 36 Gy after total removal, 40 Gy for tumors less than 2.5 cm in diameter, 45 Gy for those 2.5–4.0 cm, and 50 Gy for those greater than 4.0 cm, with 1.6–1.8-Gy daily fractions. Patients underwent irradiation of the primary tumor site or cerebrospinal axis (20–24 Gy), depending on findings at diagnosis. No chemotherapy was allowed.

RESULTS: All patients completed radiation therapy. Thirty-five patients were treated according to protocol, and three with relatively slow tumor regression or presence of a cyst received additional radiation (5–7 Gy, 50–52 Gy total). Ten-year overall and relapse-free survival rates were 91% and 95%, respectively. Two patients developed meningeal dissemination, but none had local failure. Treatment complications included chordoma in one patient and internal carotid artery occlusion in another. No treatment-related decline of performance status was observed in the other patients.

CONCLUSION: All tumor volume–based radiation doses were effective, without risk of local failure. Intracranial germinoma 4 cm or less in diameter can be cured with doses of 40–45 Gy. Investigation of further dose reduction seems worthwhile. Radiation therapy alone with these doses should be compared with ongoing chemotherapeutic protocols plus low-dose (24–30-Gy) irradiation in future studies.

Index terms: Brain neoplasms, 10.361 • Brain neoplasms, therapeutic radiology, 10.1269 • Dosimetry • Germ cell neoplasm, 10.361 • Spinal cord, therapeutic radiology, 30.1269


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Although combined radiation therapy and chemotherapy is now being investigated at many institutions, radiation therapy is the standard treatment for intracranial germinoma, producing a cure rate of more than 90% (1,2). Despite the fact that germinoma has the highest radiosensitivity among all primary brain tumors, a radiation dose of 50 Gy has been most commonly used to treat this tumor (1–5). It seems that the dose of 50 Gy was chosen empirically because it is usually safe for normal brain tissue in terms of the low incidence of brain necrosis. Although radiation necrosis does not develop, other adverse effects of radiation, such as anterior pituitary dysfunction and cognitive decline, may occasionally develop at this dose level (6,7). Since lymph node metastases of testicular seminoma, which is histologically identical to intracranial germinoma, can be treated successfully with 25–35 Gy of radiation (8), it seems reasonable to investigate the possibility of radiation dose reduction for intracranial germinoma. In fact, previous data including our own suggested that the disease could be cured with doses lower than 50 Gy, at least in some patients (3,4,9).

In view of these observations, we conducted a prospective study to investigate whether the radiation dose could be reduced for small or middle-sized germinomas without jeopardizing the high cure rate. Preliminary results of this study have been reported previously, together with our retrospective series (10). The purpose of this study was to describe mature results of this study after a median follow-up of 10 years.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Patients with histologically proved intracranial germinoma or tumor that fulfilled our criteria (11) for clinical diagnosis of intracranial germinoma were eligible. The criteria consisted of the typical age range (8–32 years), tumor site, magnetic resonance (MR) imaging and/or computed tomographic (CT) findings (homogeneously enhancing mass), and prompt response to irradiation (>80% reduction in mean diameter at 15–20 Gy). Patients suspected of having germinoma on radiologic and clinical grounds entered the study; all fulfilled the criteria for response to irradiation, so none were excluded from the study. Patients with a mixed germ cell tumor were excluded. Patients with recurrence following primary chemotherapy alone were eligible, and five such patients were included. However, patients who developed recurrence after radiation therapy were not included. This study was performed according to the Declaration of Helsinki, and informed consent was obtained from all patients.

Pretreatment contrast material–enhanced MR imaging and/or CT brain examinations both before and after surgery (if any) were mandatory. MR imaging of the whole spine was not mandatory and was performed in only four patients because of limited machine time. Cytologic examination of the cerebrospinal fluid (CSF) was performed whenever possible, except in patients suspected of having elevated intracranial pressure. Tumor markers such as human chronic gonadotropin, carcinoembryonic antigen, and {alpha}-fetoprotein, were routinely checked after 1987. Patients with elevated carcinoembryonic antigen and/or {alpha}-fetoprotein levels were excluded, but those with a human chorionic gonadotropin level up to 1,000 IU/mL were eligible.

Accrual of 35–40 patients was planned; with this patient number, a decrease in the survival and/or relapse-free rates exceeding 20% from the standard 5-year rates of 95% would be detectable, with a one-sided significance level of 0.05 and a power of 0.8 (12). Between April 1985 and July 1995, 38 patients were enrolled in the study. The patient and tumor characteristics are shown in Table 1. Pretreatment performance status of the patients was evaluated before radiation therapy after surgery (if any). Pituitary function was evaluated in patients with a suprasellar lesion.


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  		TABLE 1. Pretreatment Patient and Tumor Characteristics
 
The radiation therapy protocol was as follows. The treatment volume was chosen to be either the primary tumor site or the craniospinal axis (plus boost to the primary site) on the basis of the clinical and radiologic findings; that is, patients with positive CSF cytologic findings and/or CSF dissemination (including intraventricular dissemination) underwent whole-neuraxis irradiation, while all other patients underwent primary tumor site irradiation. However, craniospinal irradiation was also administered in five patients who wished it or whose families wished it despite negative CSF cytologic findings or dissemination.

Our methods for focal and craniospinal irradiation were described previously (10,11). For focal irradiation, the anteroposterior and the four lateral opposing fields were usually used unless other techniques were considered better. The treatment volume included the tumor volume determined at MR imaging and/or CT before surgery (if any) plus at least 2-cm margins and the lateral and third ventricles to 3 cm from the tumor. Most of the rest of the ventricles were usually covered with anteroposterior beams. In patients receiving craniospinal irradiation, focal boost either followed or preceded craniospinal irradiation. The whole craniospinal fields were treated on the same day. Focal irradiation after craniospinal irradiation was directed at the volume as it was presented at diagnosis.

The daily dose used was generally 1.8 Gy for focal irradiation and 1.6 Gy for craniospinal irradiation, but depending on the patient’s condition, modification of the daily dose between 1.5 and 1.8 Gy was allowed. The total radiation dose was determined on the basis of tumor size before radiation therapy (after surgery, if any). The total dose to the primary tumor site was 40 Gy for tumors less than 2.5 cm in maximum diameter, 45 Gy for tumors 2.5–4.0 cm, and 50 Gy for tumors greater than 4.0 cm. Depending on the actual response of the tumors to radiation therapy, addition or subtraction of one fraction was allowed. In patients undergoing gross total tumor removal, the total dose was 36 Gy. Total dose to the cerebrospinal axis was 20 Gy (standard dose was 20.8 Gy in 13 fractions) in patients with negative (five patients) or equivocal (five patients) CSF cytologic results or 24 Gy when CSF cytologic results were positive (11 patients) or not obtained (four patients).

Details of actual treatment are shown in Table 2. All patients completed radiation therapy. Thirteen patients underwent focal irradiation, while 25 patients underwent cerebrospinal axis irradiation. The total radiation doses were delivered as initially planned in 35 patients. In the remaining three patients, who had been scheduled to receive 45 Gy, an additional 5–7 Gy was administered because of the relatively slow disappearance of the tumor mass in two patients and the persistence of a cyst associated with the tumor in one patient. The total radiation dose was 36 Gy in two patients, 40 Gy (range, 38–42 Gy) in 13 patients, 45 Gy (range, 43–47 Gy) in 13 patients, and 50 Gy (range, 48–52 Gy) in 10 patients. Although chemotherapy was not allowed, one patient received two courses of cisplatin and etoposide after 40 Gy of radiation administered by a neurosurgeon at a referring hospital (13).


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  		TABLE 2. Details of Treatment
 
Patients were followed up usually at 3–4-month intervals until the 5th year and at 6-month intervals thereafter. MR imaging or CT was performed at 10-Gy intervals during treatment before disappearance of the tumor, at least twice a year during the follow-up period until the 5th year, and usually once a year thereafter. Tumor response and recurrence, survival, complications, performance status, and cognitive function were evaluated during the follow-up periods, but routine examination of pituitary function was not performed in patients who had no dysfunction before radiation therapy. The median follow-up for surviving patients was 120 months. One patient was lost to follow-up at 32 months, but for the other patients, minimum follow-up was 51 months. Survival and relapse-free survival rates were calculated from the date radiation therapy was started by using the Kaplan-Meier method.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Complete response to radiation therapy was observed in 35 (97%) of 36 patients who had a measurable lesion before start of radiation therapy. In one patient, who received an additional dose of 5 Gy, a small residual mass persisted even at the end of radiation therapy. Biopsy was performed; histologic results were suggestive of germinoma, but no cells were viable. In another patient, who received an additional dose of 7 Gy, a small mass also persisted at the end of radiation therapy, but according to the experience with the previous patient, it was followed up, and the mass disappeared after 1 year. In a third patient, who received an additional dose of 5 Gy, a small cyst also disappeared during the follow-up.

The Figure shows overall survival and relapse-free survival curves for the 38 patients. The 5- and 10-year survival rates were 97% (standard error, 3%) and 91% (standard error, 5%), respectively. The corresponding relapse-free rates were both 95% (standard error, 4%). No patient developed local recurrence, but two developed CSF dissemination.



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  		Figure 1. Overall ({circ}) and relapse-free ({bullet}) survival curves. The 10-year survival rate of 91% and the 10-year relapse-free survival rate of 95% are not different from those usually obtained with 50 Gy or higher doses of radiation.

 
One patient had a pineal tumor with positive CSF cytologic results but no evidence of intraventricular or subarachnoid dissemination. Craniospinal irradiation with 23.7 Gy in 15 fractions and a focal boost up to 39.6 Gy was administered, but 50 months later the patient developed dissemination at the interpeduncular cistern. He died at the referring hospital after ineffective repeat chemotherapy. Another patient had a suprasellar tumor and negative CSF cytologic results. Focal irradiation with 39.6 Gy was administered, but dissemination developed at the medulla oblongata 42 months later. He moved to another hospital near his hometown, and we recommended that the attending radiation oncologists perform craniospinal irradiation. However, the patient and his family did not accept this recommendation, and he received irradiation only at the recurrent site. He developed further dissemination at multiple other sites and died of the disease.

One patient developed chordoma within the irradiated volume in the frontal lobe 66 months after radiation therapy (45 Gy). The tumor was resected, and the patient survived without recurrence at 133 months. Another patient who had received 40 Gy developed occlusion of the internal carotid artery 74 months after radiation therapy and died of multiple organ failure thereafter. This patient developed encephalitis 3 years after radiation therapy and since then had a poor status. Therefore, it is unclear whether irradiation was the sole cause of the vascular event. In the other patients, treatment-related decline of performance status or severe neurocognitive deficits were not observed. No patient who had normal anterior pituitary function before radiation therapy developed clinical symptoms of pituitary dysfunction. Two of four patients who had amenorrhea regained a spontaneous menstrual cycle after radiation therapy.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
Our findings revealed that intracranial germinomas 4 cm or less in diameter can usually be cured with radiation doses of 40–45 Gy. Regarding the radiation dose required to control each germinoma, it may be possible, to some extent, to estimate the dose from the actual response of the tumor to irradiation, because this tumor quickly responds to radiation therapy. If the tumor diameter decreases to one-tenth of the pretreatment size at dose x, the clonogenic cell number is presumed to be reduced by a factor of 10-9 at the dose 3x, if we assume exponential cell killing throughout the treatment. Since a 1-cm3 tumor contains approximately 109 clonogenic cells (14), the clonogenic cell number of a tumor of this size would become 100 at dose 3x. The clonogenic cell numbers of tumors with diameters of 2.7 cm (containing 1010 cells) and 5.8 cm (containing 1011 cells) would be 101 and 102, respectively, at the dose 3x. It would not be necessary to reduce the clonogenic cell number to zero to obtain a cure (14), so the tumor could be controlled with doses lower than the dose 3x. From our experience, 2–3-cm germinomas are usually reduced to one-tenth of their previous diameter (nearly invisible at diagnostic imaging) with a dose less than 15 Gy, and tumors of this size may be controlled with doses below 45 Gy. Although this mathematic model may be too simplistic, it would help in the estimation of the radiation dose required to control intracranial germinomas.

Previous findings suggest that radiation doses lower than 50 Gy are associated with an increased local recurrence rate. Sung et al (15) found two local recurrences in six patients receiving less than 50 Gy, while there was no local recurrence in eight patients receiving 50 Gy or more. However, in their study, the incidence of CSF dissemination was high in both dose groups, and appropriate assessment of local control might have been precluded. Amendola et al (16) reported four local recurrences among nine patients receiving less than 50 Gy, but most of these patients had been treated before 1965, and the quality of radiation therapy might not have been as high as the current standard.

Dattoli and Newall (5) reported local and spinal recurrences in one patient receiving 39.6 Gy, while no recurrence was noted in 11 patients receiving 49 Gy or more. However, the reason why only this patient received the low dose is not described and remains unclear. In a retrospective analysis, Haddock et al (17) reported that patients receiving 40 Gy or less had worse outcomes, but marginal recurrences and failures with histiologic findings not consistent with germinoma were included in this group. Therefore, from these study findings, it may not be concluded that local recurrence would substantially increase with radiation doses lower than 50 Gy.

On the other hand, recent findings suggest that intracranial germinoma can generally be cured with doses below 50 Gy. Hardenbergh et al (2) found no recurrence in 14 patients receiving less than 50 Gy. Shirato et al (18) also found no local recurrence in 29 patients receiving 40–48 Gy with 2.0-, 2.5-, or 3.0-Gy daily fractions, although two patients developed spinal metastases. In the study of Ono et al (19), there was no recurrence in 13 patients treated with doses less than 45 Gy (mean, 39 Gy). In more recent German studies (20), no local recurrence was detected with a dose of 45 Gy. A few other investigators (9,21,22) have reported similar findings. These results of past studies and those of the current study suggest that a dose of 50 Gy is generally unnecessary for intracranial germinomas, except large ones.

The dose for CSF prophylaxis is a separate issue. Since the radiation dose for the primary tumor seems to be reducible, the dose for the cerebrospinal axis may also be reduced. We used 20 Gy for patients with negative or equivocal CSF cytologic results and have not found CSF dissemination. However, we found CSF dissemination in a patient who definitely had positive CSF cytologic results and who was treated with 23.7 Gy in the CSF space. Because of the limited number of patients, it is unclear whether this recurrence was due to underdosage or other unknown causes (a small proportion of germinomas do recur even after higher-dose radiation therapy), and further experience is required to determine the optimal dose for CSF prophylaxis.

Since all radiation doses based on tumor volume used in this study were effective, without any risk of local failure, the possibility of further dose reduction may be a topic of further investigations. However, protocols including those for systemic chemotherapy have been established recently in many institutions. Chemotherapy alone seems to be associated with an unacceptably high recurrence rate (13,23,24), and this approach is not justified. Instead, the combination of chemotherapy and low-dose irradiation is now increasingly being investigated (25–28). Findings of small studies (25,27) suggest generally favorable outcomes, but the follow-up periods are still short.

Recently, Matsutani (29) reported an interim result of a Japanese multicenter trial in which three courses of carboplatin and etoposide were administered before focal irradiation with 24 Gy. Of 71 patients with germinoma treated with this protocol, five patients developed recurrence within relatively short follow-up periods (median, 25 months). Four of the five recurrences occurred outside the radiation field; this fact would suggest that these anticancer agents are relatively ineffective for CSF prophylaxis due to their inability to penetrate the blood-brain barrier. When the relatively short follow-up periods are considered, the recurrence rate may still increase, and this treatment may prove to be inferior to standard radiation therapy with craniospinal fields in high-risk patients in the future. Even if the combined treatment proves to produce cure rates equal to those obtained with higher doses of radiation therapy, toxic effects and quality of life should be compared in future studies.

In addition, the use of radiosurgery is also being investigated to minimize unnecessary irradiation of normal brain tissue (30). Thus, the optimal treatment for intracranial germinoma in terms of the best control rate with the fewest toxic effects remains to be determined. When the relatively low incidence of this tumor is considered, it is expected that ongoing and future multicenter cooperative studies will provide us with information about the optimal treatment for this highly curable disease.

In conclusion, the radiation doses used in this study, 36 Gy after total removal, 40 Gy for tumors less than 2.5 cm in diameter, 45 Gy for 2.5–4.0-cm tumors, and 50 Gy for tumors greater than 4.0 cm, were effective for the local control of intracranial germinomas. These results form a basis from which to launch a randomized phase 3 trial to further investigate the best treatment for this tumor.


   FOOTNOTES
 
Abbreviation: CSF = cerebrospinal fluid

Author contributions: Guarantor of integrity of entire study, Y.S.; study concepts and design, Y.S.; definition of intellectual content, Y.S.; literature research, Y.S.; clinical studies, all authors; data acquisition, Y.S., K.S., N.O.; data analysis, Y.S.; statistical analysis, Y.S.; manuscript preparation and editing, Y.S.; manuscript review and final version approval, all authors.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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Pathologic Diagnosis Is Necessary in the Management of Pineal Region and Suprasellar Tumors
Simon S. Lo, et al.
Radiology Online, 20 May 2003 [Full text]
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