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Shoji Yomo, Kyota Oda and Kazuhiro Oguchi

OBJECTIVE

Two-session Gamma Knife surgery (GKS) has recently been demonstrated to be an effective and less-invasive alternative for large brain metastases not treatable by microsurgical resection. This raises the clinical question of whether the 2-session GKS strategy further improves treatment outcomes for patients with symptomatic midsize brain metastases (2–10 cm3) as compared to single-session GKS. The present study aimed to compare the local therapeutic effects and toxicities of single-session and 2-session GKS for treating these lesions.

METHODS

Patients with focal neurological deficits attributable to midsize brain metastases who underwent upfront GKS during the period from 2010 to 2018 were retrospectively identified from an institutional database. Patients for whom both post-GKS imaging studies and neurological evaluations from outpatient visits were available were eligible. Using propensity score–matching (PSM) analysis, unique matched pairs which had a similar likelihood of receiving 2-session GKS were generated. The main outcome measure was a composite of imaging and/or neurological worsening of the lesion of interest. Functional improvement and overall survival (OS) were also compared between the 2 treatment arms.

RESULTS

In total, 219 cancer patients with 252 symptomatic midsize brain metastases were eligible. Of these 252 tumors, 176 and 76 were treated with single- and 2-session GKS, respectively. After PSM, 68 pairs of tumors were obtained. The Gray test showed that 2-session GKS achieved a longer local progression–free interval than single-session GKS (1-year local control rate: 84% vs 53%; HR 0.31, 95% CI 0.16–0.63, p = 0.001). Two-session GKS was also associated with greater functional improvement in KPS scores (mean 18.3 ± 14.6 vs 12.8 ± 14.1, p = 0.040). The median OS did not differ significantly between single- and 2-session GKS (15.6 vs 24.7 months; HR 0.69, 95% CI 0.44–1.10, p = 0.11).

CONCLUSIONS

Two-session GKS achieved more durable local tumor control and greater functional improvement than single-session GKS for patients with symptomatic midsize brain metastases, although there was no OS advantage.

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Shoji Yomo, Yasser Arkha, Anne Donnet and Jean Régis

Gamma Knife surgery (GKS) is widely recognized as an effective, minimally invasive treatment for intractable trigeminal neuralgia, but the role of GKS in glossopharyngeal neuralgia (GPN) remains unclear. This study involved 2 patients with medically intractable GPN who were treated using GKS. One patient required 2 treatments because of a recurrence of symptoms (at maximum doses of 60 and 70 Gy), and the other patient had a single intervention (at a maximum dose of 75 Gy). The GKS target was the distal part of the glossopharyngeal nerve. Patients were investigated prospectively, treated, and then assessed periodically with respect to pain relief and neurological function. Complete pain relief was achieved initially after all 3 interventions. The first patient was pain free without medication for 2 months after the first treatment (60 Gy) and for 4 months after the second treatment (70 Gy). The second patient (treated with 75 Gy) was still pain free without medication at the last follow-up (12 months). Neither patient had any neurological complications. The initial response of GPN to low-dose GKS was favorable, but symptoms may recur. No adverse neurological effects were observed in any of the lower cranial nerves. It will be necessary to investigate the optimal radiation dose and target of GKS for achieving long-term pain relief in GPN.

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Douglas Kondziolka

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Shoji Yomo, Romain Carron, Jean-Marc Thomassin, Pierre-Hugues Roche and Jean Régis

Object

The aim of this study was to perform an accurate analysis of changes in hearing in patients with vestibular schwannoma (VS) who have undergone Gamma Knife surgery (GKS) and distinguish the impact of radiosurgery from the natural course of hearing deterioration due to the tumor itself.

Methods

This study was a retrospective review of prospectively collected patient data. A group of 154 patients with unilateral nonsurgically treated VS was conservatively monitored for more than 6 months and then treated with GKS between July 1997 and September 2005. They were followed up with serial clinical examination, MRI, and audiometry. The annual hearing decrease rate (AHDR) was measured before and after radiosurgery, and the possible prognostic factors for hearing preservation were investigated.

Results

The mean dose prescribed to the tumor margins was 12.1 Gy. The mean radiological follow-up period after GKS was 60 months (range 7–123 months). The tumor control rate was 94.8%, and 8 patients underwent subsequent intervention due to tumor progression. The mean audiological follow-up times before and after GKS were 22 and 52 months, respectively. The mean AHDRs before and after GKS were 5.39 dB/year (95% CI 3.31–7.47 dB/year) and 3.77 dB/year (95% CI 3.13–4.40 dB/year), respectively (p > 0.05). The mean pre- and post-GKS AHDRs in patients who initially had Gardner-Robertson (GR) Class I hearing were −0.57 dB/year (95% CI −2.95 to 1.81 dB/year) and 3.59 dB/year (95% CI 2.52–4.65 dB/year), respectively (p = 0.007). The mean pre- and post-GKS AHDRs in patients who initially had GR Class II hearing were 5.09 dB/year (95% CI 1.36–8.82 dB/year) and 4.98 dB/year (95% CI 3.86–6.10 dB/year), respectively (p > 0.05). A subgroup of 80 patients had both early and late post-intervention AHDR assessment (with early referring to the period from GKS to the assessment closest to the 2-year follow-up point and late referring to the period from that assessment to the most recent one); in these patients, the mean early post-GKS AHDR was 5.86 dB/year (95% CI 4.25–7.50 dB/year) and the mean late post-GKS AHDR was 1.86 dB/year (95% CI 0.77–2.96 dB/year) (p < 0.001). A maximum cochlear dose of less than 4 Gy was found to be the sole prognostic factor for hearing preservation.

Conclusions

The present study demonstrated the absence of an increase in AHDR after radiosurgery as compared with the preoperative AHDR. There was even a trend indicating a reduction in the annual hearing loss after radiosurgery over the long term. To fully elucidate a possible protective effect of radiosurgery, longer-term follow-up with a larger group of patients will be required.

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Tetsuo Sasaki, Yuichi Nakamura, Shoji Yomo, Yasuyuki Sekiguchi, Kunihiko Kodama, Yozo Ichikawa and Kazuhiro Hongo

A new approach in carotid endarterectomy (CEA) was developed for high carotid artery lesions. With the authors' use of the posterior cervical triangle approach, 20 patients with a high carotid artery lesion were successfully treated with CEA. Accessory nerve palsy in 1 patient and hoarseness in 4 patients were encountered postoperatively as transient complications. There were no permanent procedure-related complications. Although this method has some risks, it is a useful method in CEA for high carotid artery lesions.

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Tetsuya Goto, Yuichiro Tanaka, Kunihiko Kodama, Shoji Yomo, Yosuke Hara, Atsushi Sato and Kazuhiro Hongo

✓ Intraoperative electrophysiological monitoring is essential for minimally invasive neurosurgery. The authors developed an innovative recording method using a staple electrode, consisting of a surgical skin staple and an integrated circuit (IC) test clip with a cable. The staple is put on the patient's skin after the induction of general anesthesia. After head fixation, the IC test clip is simply hooked to the staple. The authors used this method for recording in 158 consecutive cases. It took only a few minutes to set up 4–18 staple electrodes in each case. None of the staple electrodes became disconnected unintentionally, and the initial impedance was kept throughout the procedures. The authors conclude that the staple electrode is superior to conventional disc or needle electrodes in speed of setup, electrical stability, and cost-effectiveness and recommend its routine use for intraoperative electrophysiological monitoring.

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Takashi Shuto, Atsuya Akabane, Masaaki Yamamoto, Toru Serizawa, Yoshinori Higuchi, Yasunori Sato, Jun Kawagishi, Kazuhiro Yamanaka, Hidefumi Jokura, Shoji Yomo, Osamu Nagano and Hidefumi Aoyama

OBJECTIVE

Previous Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5–10 brain metastases (BMs) compared with those with 2–4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non–small cell lung cancer (NSCLC).

METHODS

Patients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm3, and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70% or better.

RESULTS

Among 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2–4 tumors, n = 342), and group C (5–10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95% CI 0.842–1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1%) patients during the median post-SRS period of 9.3 months (IQR 4.1–17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5%, 10.0%, and 12.6%, respectively (group B vs C: HR 1.344; 95% CI 0.768–2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7% or higher, and no significant differences among the 3 groups were found.

CONCLUSIONS

In this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5–10 versus 2–4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5–10 BMs.

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Toru Serizawa, Masaaki Yamamoto, Yoshinori Higuchi, Yasunori Sato, Takashi Shuto, Atsuya Akabane, Hidefumi Jokura, Shoji Yomo, Osamu Nagano, Jun Kawagishi and Kazuhiro Yamanaka

OBJECTIVE

The Japanese Leksell Gamma Knife (JLGK)0901 study proved the efficacy of Gamma Knife radiosurgery (GKRS) in patients with 5–10 brain metastases (BMs) as compared to those with 2–4, showing noninferiority in overall survival and other secondary endpoints. However, the difference in local tumor progression between patients with 2–4 and those with 5–10 BMs has not been sufficiently examined for this data set. Thus, the authors reappraised this issue, employing the updated JLGK0901 data set with detailed observation via enhanced MRI. They applied sophisticated statistical methods to analyze the data.

METHODS

This was a prospective observational study of 1194 patients harboring 1–10 BMs treated with GKRS alone. Patients were categorized into groups A (single BM, 455 cases), B (2–4 BMs, 531 cases), and C (5–10 BMs, 208 cases). Local tumor progression was defined as a 20% increase in the maximum diameter of the enhanced lesion as compared to its smallest documented maximum diameter on enhanced MRI. The authors compared cumulative incidence differences determined by competing risk analysis and also conducted propensity score matching.

RESULTS

Local tumor progression was observed in 212 patients (17.8% overall, groups A/B/C: 93/89/30 patients). Cumulative incidences of local tumor progression in groups A, B, and C were 15.2%, 10.6%, and 8.7% at 1 year after GKRS; 20.1%, 16.9%, and 13.5% at 3 years; and 21.4%, 17.4%, and not available at 5 years, respectively. There were no significant differences in local tumor progression between groups B and C. Local tumor progression was classified as tumor recurrence in 139 patients (groups A/B/C: 68/53/18 patients), radiation necrosis in 67 (24/31/12), and mixed/undetermined lesions in 6 (1/5/0). There were no significant differences in tumor recurrence or radiation necrosis between groups B and C. Multivariate analysis using the Fine-Gray proportional hazards model revealed age < 65 years, neurological symptoms, tumor volume ≥ 1 cm3, and prescription dose < 22 Gy to be significant poor prognostic factors for local tumor progression. In the subset of 558 case-matched patients (186 in each group), there were no significant differences between groups B and C in local tumor progression, nor in tumor recurrence or radiation necrosis.

CONCLUSIONS

Local tumor progression incidences did not differ between groups B and C. This study proved that tumor progression after GKRS without whole-brain radiation therapy for patients with 5–10 BMs was satisfactorily treated with the doses prescribed according to the JLGK0901 study protocol and that results were not inferior to those in patients with a single or 2–4 BMs.

Clinical trial registration no.: UMIN000001812 (umin.ac.jp)

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Motohiro Hayashi, Taku Ochiai, Kotaro Nakaya, Mikhail Chernov, Noriko Tamura, Takashi Maruyama, Shoji Yomo, Masahiro Izawa, Tomokatsu Hori, Kintomo Takakura and Jean Regis

Object

Gamma Knife surgery (GKS) is becoming a standard treatment for vestibular schwannoma (VS); it is ranked with microsurgery from the perspective of tumor control and audiofacial nerve function preservation. A new treatment technique that will improve the tumor shrinkage ratio, shorten the patient's recovery time, and even recover some cranial nerve function is described.

Methods

Along with advances in the GKS system, the authors have developed magnetic resonance imaging sequences specific to particular treatments. These newly developed sequences provide much clearer visualization of the distribution of the cranial nerves, especially in the area from the cisterns to the internal acoustic meatus. Magnetic resonance images have been fused with computed tomography scans to facilitate better delineation of the anatomical relationships. These dose-planning images allow for a higher isodose line (80%) inside the tumor. The aim is to shrink the tumor and not just to control it. To date 130 patients have been treated with GKS in conjunction with this new technique. Of the 130, 91 patients were observed for more than 12 months. The tumor shrinkage rate was 65.9% (76% for patients with > 24 months of follow up), the facial nerve preservation rate was 98.9%, the hearing preservation rate was 92.3%, and four (4%) of 91 patients recovered hearing function. Transient tumor enlargement was observed in most cases, but no severe complications were found.

Conclusions

Although these results are preliminary, they would appear to represent a potential breakthrough in the treatment of VS. Longer follow-up periods and additional cases will firmly establish this method as an absolute treatment option for patients with a VS.

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Motohiro Hayashi, Taku Ochiai, Kotaro Nakaya, Mikhail Chernov, Noriko Tamura, Shoji Yomo, Masahiro Izawa, Tomokatsu Hori, Kintomo Takakura and Jean Regis

✓Gamma Knife surgery (GKS) is image-guided surgery for brain tumors. Precise tumor visualization is needed in dose planning to control tumor progression. The surrounding vital structures must also be clearly defined to allow the preservation of their function. A special magnetic resonance (MR) imaging sequence was chosen for use with GKS to treat skull base and suprasellar tumors.

Gadolinium-enhanced 0.5-mm constructive interference in steady-state (CISS) slices were obtained in skull base and suprasellar tumors. Each structure that was adjacent to the tumor could be visualized more clearly by using this imaging technique because the tumor became transparent even though there was no change in the appearance of the surrounding structures after injection of Gd. Use of this technique in acoustic tumors allowed the seventh and eighth cranial nerves to be visualized in the cisternal and intrameatal portions; both of which were distinguishable from the tumor. Suprasellar tumor could be distinguished from the adjacent optic pathway. The use of Gd-enhanced CISS imaging allowed for optimal dose planning with very high conformity in every tumor. Achieving this high conformity allowed the preservation of adjacent structures and their functions.

Establishing optimal dose planning in brain tumors is very important to overcome the problem of producing new neurological deficits in patients who may already be suffering disease-related deficits. The use of this special CISS MR imaging sequence may help accomplish this goal.