Dynamic changes of bone metastasis predict bone‐predominant status to benefit from radium‐223 dichloride for patients with castration‐resistant prostate cancer

Hashimoto, Kimio; Miyoshi, Yasuhide; Shindo, Tetsuya; Hori, Masakazu; Tsuboi, Yasumasa; Kobayashi, Ko; Fukuta, Fumimasa; Tanaka, Toshiaki; Miyamoto, Shintaro; Maehana, Takeshi; Okada, Manabu; Nishiyama, Naotaka; Yanase, Masahiro; Kato, Ryuichi; Hara, Hiroshi; Kunishima, Yasuharu; Takahashi, Atsushi; Hinotsu, Shiro; Sakata, Koh‐ichi; Kitamura, Hiroshi; Uemura, Hiroji; Masumori, Naoya

doi:10.1002/cam4.3459

Cited by 13 publications

(12 citation statements)

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“…While there have been many reports on patients treated with Ra‐223 in Japan, none have described the improvement in the OS with Ra‐223 compared with a cohort not treated with Ra‐223 (Table 2). 5–12 Therefore, in the present study, we investigated whether or not Ra‐223 improves the OS in Japanese patients using a large‐scale healthcare fee database.…”

Section: Discussionmentioning

confidence: 99%

“…Ra‐223 is widely used in daily clinical practice in Japan for bone metastatic CRPC, with a total of 5852 vials administered annually in 2018 4 . There were several studies to confirm that completion of six‐course Ra‐223 showed longer survival compared to the one‐ to five‐course group and examined the factors who showed longer prognosis who received Ra‐223 in Japanese patients 5–14 . However, almost all studies of Ra‐223 from Japan have used patient cohorts receiving Ra‐223, with no non‐Ra‐223 induction patient cohorts included 2,5,7,10,11 …”

Section: Introductionmentioning

confidence: 99%

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Administration of radium‐223 and the prognosis in Japanese bone metastatic castration‐resistant prostate cancer patients: A large database study

et al. 2022

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Administration of radium‐223 and the prognosis in Japanese bone metastatic castration‐resistant prostate cancer patients: A large database study

et al. 2022

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“…Despite increasing clinical experience with Ra-223 given to mCRPC patients, clinical variables useful for predicting response to that radiopharmaceutical and also survival remain di cult to identify. Scoring systems reported include baseline Eastern Cooperative Oncology Group (ECOG) performance status, levels of hemoglobin, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and prostate speci c antigen (PSA), PSA doubling time (PSADT), completion of six cycles of Ra-223, as well as other factors [5][6][7][8][9][10][11][12][13][14][15]. However, a validated and simple model for clinicians to assess which patients will most likely bene t from Ra-223 treatment remains to be elucidated.…”

Section: Introductionmentioning

confidence: 99%

Novel nomogram developed for determining suitability of metastatic castration-resistant prostate cancer patients to receive maximum benefit from radium-223 dichloride treatment—Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial

Kitajima

Igeta

Kuyama

et al. 2022

Eur J Nucl Med Mol Imaging

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Purpose: To develop a novel nomogram for determining radium-223 dichloride (Ra-223) treatment suitability for metastatic castration resistant prostate cancer (mCRPC) patients. Methods: This Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial was a retrospective multicenter investigation enrolled 258 mCRPC patients in Japan with Ra-223 treatment at 14 hospitals between June 2016 and August 2020, with bone scintigraphy ndings before treatment, clinical data, and survival outcome available. A nomogram was constructed using prognostic factors for overall survival (OS) based on a least absolute shrinkage and selection operator Cox regression model. Results: Within median 17.4 months after initial Ra-223 treatment, 124 patients (48.1%) died from prostate cancer. Predictive factors included (1) sum of prior treatment history (score 0, never prior new hormone therapy, never prior chemotherapy, and ever prior bisphosphonate/denosumab treatment), (2) Eastern Cooperative Oncology Group (ECOG) performance status, (3) prostate-speci c antigen doubling time (PSADT), (4) hemoglobin, (5) lactate dehydrogenase (LDH), and (6) alkaline phosphatase (ALP) levels, and (7) automated bone scan index (aBSI) value based on bone scintigraphy. The nomogram using those factors showed good discrimination, with apparent and optimism-corrected Harrell's concordance index values of 0.748 and 0.734, respectively. Time-dependent area under the curve values at one, two, and three years were 0.771, 0.818, and 0.771, respectively. A two-year survival calibration plot indicated consistent predicted and observed values without large discrepancy. Conclusion: This novel nomogram including aBSI to select mCRPC patients to receive Ra-223 with signi cantly prolonged OS possibility was found suitable for assisting therapeutic decision making. PatientsThis investigation was conducted as a retrospective multicenter study titled Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial. Approval was granted by the ethical committee at the core center Hyogo Medical University (No. 3662) as well as all participating hospitals. Patients treated at 14 different institutions (

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“…Based on these findings, Ra-223 was established as a standard treatment modality for mCRPC patients with predominant bone disease and no visceral metastases [4][5][6]. The approved regimen of Ra-223 is an intravenous injection of 55 kBq/kg of Ra-223, every 4 weeks (q4w), for six cycles [1,4].…”

Section: Introductionmentioning

confidence: 99%

“…The biological effectiveness of a radionuclide therapy is dose-dependent [7]. Saad et al conducted a phase IIIb, single-arm study in the setting of an international early access program (iEAP) [8] that evaluated the correlation between the number of treatment cycles of Ra-223 (1-4 vs. [5][6] and the OS using a post hoc analysis [7]. The primary endpoints of this study were the safety and survival of patients treated with Ra-223 for symptomatic or asymptomatic mCRPC.…”

Section: Introductionmentioning

confidence: 99%

A novel prediction model for the completion of six cycles of radium-223 treatment and survival in patients with metastatic castration-resistant prostate cancer

et al. 2021

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Purpose We evaluated the predictive factors for completion of all six cycles of radium-223 (Ra-223) treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). We also developed a novel prediction model for Ra-223 treatment completion using these predictors. Methods We retrospectively reviewed data from 122 patients with mCRPC who were treated with Ra-223. The predictive factors for the completion of six cycles of Ra-223 treatment were evaluated. Statistically significant predictive factors were then used to develop a prediction model for treatment completion. Finally, using this prediction model, we classified the overall survival (OS) of the entire cohort into three groups. Results We identified three significant variables as the predictive factors for treatment completion: baseline alkaline phosphatase (ALP) level, baseline hemoglobin (Hb) level, and baseline pain. The three groups generated using the prediction model were: group 1 (patients with three predictive factors, i.e., ALP < median, Hb ≥ median, and no pain), group 2 (patients with one to two predictive factors), and group 3 (patients without any predictive factors). The treatment completion rates differed between the three groups significantly. Furthermore, the OS also differed among the groups significantly. Conclusion Our study suggested that the baseline ALP level, baseline Hb level, and baseline pain were the predictive factors of completion of all six cycles of Ra-223 treatment in patients with mCRPC. Our prediction model consisting of these factors could predict not only the completion of Ra-223 treatment, but also the post-treatment survival. This model can thus be useful for selection of patients for Ra-223 treatment.

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Dynamic changes of bone metastasis predict bone‐predominant status to benefit from radium‐223 dichloride for patients with castration‐resistant prostate cancer

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 13 publications

References 24 publications

Administration of radium‐223 and the prognosis in Japanese bone metastatic castration‐resistant prostate cancer patients: A large database study

Administration of radium‐223 and the prognosis in Japanese bone metastatic castration‐resistant prostate cancer patients: A large database study

Novel nomogram developed for determining suitability of metastatic castration-resistant prostate cancer patients to receive maximum benefit from radium-223 dichloride treatment—Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial

A novel prediction model for the completion of six cycles of radium-223 treatment and survival in patients with metastatic castration-resistant prostate cancer

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