Epirubicin and Non-Muscle Invasive Bladder Cancer Treatment: A Systematic Review
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Adverse Events after Intravesical Instillations with Epirubicin
3.2. EPI versus BCG
3.3. EPI versus MMC
3.4. EPI versus GEM
3.5. Chemohyperthermia with Epirubicin
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study/Year | Country | No pts. m/f | No. Instillations | Adverse Reactions No. Patients (%) |
---|---|---|---|---|
Melekos et al., 1993 | Greece | 84/15 | 6–8 (50 mg EPI in 50 mL saline) | Cystitis (34%) and hematuria (15%) |
Eto et al., 1994 | Japan | 98/16 | (30 mg EPI/30 mL saline) Twice a week/4 weeks Once monthly/11 months | Micturition pain 6 (10.0%), pollakiuria 9 (15.0%), and hematuria 3 (5.0%) |
Ryoji et al., 1994 | Japan | 97 | 20 mg in 30 mL physiological saline, 17 times for 1 year: once immediately after TUR, once every 2 weeks for the next 4 months, and then once per month for the following 8 months | 9.3% (9/97) of the patients’ pain on urination, pollakiuria, and hematuria |
Watanabe et al., 1994 | Japan | 40/13 | 20 mg EPI was dissolved in 40 mL physiological saline, 17 instillations, seven times at intervals of 2 weeks. Finally, eight intravesical instillations were performed at 1-month intervals. A total of 17 intravesical injections were given over a period of about 1 year | 3 cases (5.7%), and most were symptoms of bladder irritation such as pollakiuria |
Ali-El-Dein et al., 1997 | Egypt | 206/47 | 8 (1/week) (50 mg EPI/40 mL saline) 1 monthly for 12 months (maintenance) | 40 to 56% local side effects (contracted bladder) |
Okamura et al., 1998 | Japan | 110/28 | (40 mg/mL in normal saline) Arm A (17 instillations) vs. Arm B (6 instillations) | Miction pain and frequency in 10 (7.2%) patients and gross hematuria in 1 (0.7%) |
Melekos et al., 1992 | Greece | 55/10 | 6 weeks, 1/monthly | Cystitis: 27.9%pts, hematuria 14%, fever 2.3%, nausea and vomiting 2.3%, generalized skin rash 2.3% |
Torelli et al., 2001 | Italy | 130/39 | (80 mg/instillation) started within 20 days after TUR—once monthly for 11 months | Chemical cystitis in 9 patients (6.7%), bacterial cystitis in 2 (1.5%) |
Bassi et al., 2002 | Italy | 26/4 | 6 80 mg EPI (in 50 mL sterile saline) | Grade of toxicity: G1, G2, G3, G4 Bladder spasms/dysuria 4 (13.7%), 9 (31%), 2 (6.89%)– Hematuria–3 (10.3%)– Fever–1 (3%)– |
Mitsumori et al., 2004 | Japan | 51/18 | A, delayed (first instillation 7 days after TURBT) and low-dose (30 mg once every 2 weeks, six times) instillations; B, early (three instillations before 7 days after TURBT) and low-doseinstillations; C, delayed and high-dose (30 mg once weekly 12 times) instillations; D, early and high-doseinstillations | 18 patients (26%): irritated bladder 13 pts (18.84%), hematuria 1 pt (1.44%), and bacterial cystitis 4 pts (5.79%) |
Kato et al., 2015 | Japan | 71/17 | 30 mg of EPI plus 200 mg of Ara-C dissolved in 20 mL of physiological saline weekly for the first year, then every 2 weeks for the second year, once a month for the third year, and once every 3 months during the fourth and fifth years | Severe, reversible cystitis 2 pts (4.5%) |
Study/Year | Country | Design (Period) | No pts. m/f | Age Median (IQR) | Stage | Grade | Variables | Recurrence | Progression | Follow-Up |
---|---|---|---|---|---|---|---|---|---|---|
Duchek et al., 2009 | Sweden | Prospective study February 1999–December 2006 | 256 | 67 | T1 | BCG G2 35% (28) 32% (26) EPI G3 91% (72) 92% (74) | drug, size, multifocality, age, Re-TUR, grade, concomitant CIS | 34 pts (BCG) vs. 47 pts (EPI&iFN) | No difference regarding the progression | 2 years |
Marttila et al., 2016 | Finland | 1997–2008 | 272 | 71/70 | pTa/pT1/urothelial neoplasm 103/10/2 (90/9/2) 108/6/0 (95/5/0) | BCG G1 75% (65) G2 27% (24) EPI/IFN G1 79% (69) G2 24% (21) | gender, age, no. of recurrences, time to recurrence, multifocality, cytology grade, tumor diameter, perioperative Epirubicin | After 5 years, the recurrence-free estimate of the BCG group was significantly better than that of the EPI/IFN group, 59% versus 38%, respectively | There was no significant difference in the probability of progression or overall survival | BCG/EPI 7.5 years/7.4 years |
Tozawa et al., 2001 | Japan | March 1990 to February 1999 | 72 | 70 years | BCG pTa 13 pT1 37 EPI pTa 7 pT1 57 | BCG G1 14 G2 34 G3 2 EPI G1 6 G2 50 G3 8 | age, sex, tumor grade, stage, number of recurrences before TURBT | 32.0% (16/50) in BCG-treated patients 26.1% (6/23) of patients with chemoimmunotherapy | However, the comparison of Kaplan–Meier curves at the 3-year time point revealed a lower tumor recurrence in the BCG monotherapy group, significant at a level of p = 0.026 | 2 years |
Melekos et al., 1996 | Greece | Prospective Study | 132 | BCG/EPI 65.3/67.2 | BCG Ta 34 T1 24 EPI Ta 38 T1 23 | BCG G1 12 G2 34 G3 12 EPI G1 12 G2 35 G3 14 | gender, age, primary tumors, multiple tumors, stage, grade, previous intravesical therapy, concomitant CIS | Free of recurrence 44% for Epirubicin vs. 55% for BCG 10 (16.4%) in the Epirubicin group and 7 (12%) in the BCG | 10 (16.4) EPI vs. 7 (12) BCG | 2 years |
Chi Wai Cheng et al., 2004 | China | Between July 1988 and September 1999 | 36 | 71.6 years | T1 | G3 | N.A | 16 pts (44.4%) | 9 pts (25%) | 12 years |
Chi Wai Cheng et al., 2005 | China | Between October 1991 and September 1999 | 209 | 69.9 years | BCG Ta 63 T1 39 EPI Ta 77 T1 29 | BCG G1 19 G2 47 G3 33 EPI G1 30 G2 55 G3 20 | N.A | 59 pts had recurrence with EPI vs. 30 pts with BCG | The 10-year Kaplan–Meier estimate for progression-free survival was 78% in BCG vs. The 10-year Kaplan–Meier estimate for progression-free survival was 74% in EPI | 23 months |
Iida et al., 2009 | Japan | Retrospective study between January 1991 and September 2005 | 93 | 73.95 years | EPI T1/G3 69 pts BCG T1/G3 24 pts | G3 | sex, age, multifocality, stage, grade, previous intravesical therapy | 31 pts (33%) | 14 pts—cancer progression | 68.7 months |
Hemdan et al., 2013 | Sweden | Prospective study Between 1999 and 2006 | 256 | BCG T1G2-3 126 pts EPI + IFN T1G2-3 124 pts | G2-3 | risk of recurrence, treatment failure, cancer-specific death | 5 years BCG vs. Epi + IFN 59% vs. 38% | Free of progression 78% and 77% | 6.9 years | |
Melekos et al., 1993 | Greece | Prospective trial | 190 | Epi 65.8 y BCG 67.1 y | EPI Ta: 42 T1: 25 BCG Ta: 41 T1: 21 | EPI G1:31 G2:25 G3:11 BCG G1:27 G2:27 G3:8 | gender, age, primary tumors, multiple tumors, stage, grade, previous intravesical therapy, concomitant CIS | EPI 27 (40.3) BCG 20 (32.2) | EPI 6 (9) BCG 4 (6.5) | 32.9 months |
Study/Year | Country | Design (Period) | No pts. m/f | Age Median (IQR) | Stage | Grade | Variables | Recurrence | Progression | Follow -Up |
---|---|---|---|---|---|---|---|---|---|---|
Bono et al., 1996 | Italy | October 1986–April 1989 | 108 | 65.5 years | Study (30,864) (MMC) Ta in 82 patients (76%) T1 in 26 (24%) Study (30,869) (EPI) Ta in 35 patients (87.5%) T1 in 5 patients (12.5%) | Study (30,864) (MMC) G1 in 33 cases (30.6%), G2 in 67 cases (62.0%), and G3 in 8 cases (7.4%). Study (30,869) (EPI) G1 in 15 cases (37.5%), G2 in 22 cases (55.0%), and G3 in 3 cases (7.5%) | <85 years, good general health, multiple primary or recurrent Ta-T1 | Treated with MMC 19 pts–19.79% | progression in 20% of patients | N.A |
Calais da Silva et al., 1992 | Portugal | N.A | 46/14 | 68 years | EPI Ta6 patients T1 23 patients MMC Ta 1 patient T1 17 patients | EPI G1—11 patients G2—14 patients G3—7 patients MMC G1—10 patients G2—16 patients G3—2 patients | Single/multiple tumor Primary-recurrent | EPI Primary Ta 6 patients with 1 recurrence; primary T1-23 patients with 8 recurrences, and recurrent T3 patients with 3 recurrences. MMC Ta 1 patient with no recurrence; primary T1 17 patients with 5 recurrences; recurrent Ta 2 patients with no recurrences, and T 8 patients with 3 recurrences. | N.A | 17.7 months |
Study/Year | Country | Design (Period) | No pts. m/f | Age Median | Stage | Grade | Variables | Recurrence | Progression | Follow -Up |
---|---|---|---|---|---|---|---|---|---|---|
Wang et al., 2019 | China | January 1996 to July 2018 | 91/33 f | N.A | N.A | GEM Low 42 (57.53%) High 31 (42.47%) EPI Low 19 (51.35%) High 18 (48.65%) | gender, age, multifocality, size, grade, risk, re-TURBT | Gemcitabine intravesical chemotherapy group was significantly related to a lower rate of recurrence in GEM (HR = 0.165, 95% CI 0.069–0.397, p = 0.000) | lower rate of progression with GEM (HR = 0.160, 95% CI 0.032–0.799, p = 0.026) | GEM 34.8 months EPI 35.9 months |
Zhang et al., 2021 | China | Retrospective study from October 2015 to October 2019 | 233/102 f | 62 years | Ta A29 B30 C36 T1 A38 B51 C38 | Low Grade A34 B40 C48 High Grade A33 B41 C26 | gender, age, size, number of tumors, stage, grade | p = 1.00—no statistical significance | p = 0.69—no statistical significance |
Study/Year | Country | Design (Period) | No. Patients Male/ Female | Chemohyperthermia | Characteristics | Age Years Mean/SD | Stage/Grade | Variables | Recurrence | Progression | Follow -Up |
---|---|---|---|---|---|---|---|---|---|---|---|
Chiancone et al., 2020 | Italy | Retrospective March 2017–February 2020 | 98/33 (33.7%) | HIVEC 72 pts. MMC vs. 26 pts. EPI | BCG failure or intolerance patients with high-risk NMIBC | 67.54 ± 7.96 vs. 64.35 ± 8.56 | Ta G3 15 (79.17%) vs. 11 (57.69%) T1G3 57 (20.83%) vs. 15 (42.31%) | Age, gender, smoking status, BMI, diabetes, number of tumors, tumor size, recurrence rate, pathologic state, concomitant CIS, tumor on RE-TURB, previously treated with MMC, BCG failure group | High-grade 14/72 (19.44%) MMC vs. 2/26 (7.69%) EPI Low-grade 3/72 (4.17%) MMC vs. 1/26 (3.85%) EPI | MMC 4/72 (5.56%) vs. EPI 2/26 (7.69%) | 10.5 vs. 14 months |
Arends et al., 2014 | The Netherlands | Prospective maintain database 2002–2013 | 160/36 (22.5%) | Synergo SB-TS 101 system 20 EPI 140 MMC | NMIBC refractory to regular intravesical treatment | 65 (range 34 to 87) | pT1 75 (46.9%), pTa 85 (53.1%), high-grade 104 (65.0%), low-grade 56 (35.0%) | Age, gender, CIS history, No. preCHT TURBTs, PreCHT T1 on histology, PreCHT highly recurrent NMIBC, PreCHT grade | 1-year RFS 64% EPi vs. 59% MMC 2-year RFS 55% EPI vs. 46% MMC, (p = 0.303) | N.A | 75.6 months |
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Chiujdea, S.; Ferro, M.; Vartolomei, M.D.; Lucarelli, G.; Bekku, K.; Matsukawa, A.; Parizi, M.K.; Klemm, J.; Tsuboi, I.; Fazekas, T.; et al. Epirubicin and Non-Muscle Invasive Bladder Cancer Treatment: A Systematic Review. J. Clin. Med. 2024, 13, 3789. https://doi.org/10.3390/jcm13133789
Chiujdea S, Ferro M, Vartolomei MD, Lucarelli G, Bekku K, Matsukawa A, Parizi MK, Klemm J, Tsuboi I, Fazekas T, et al. Epirubicin and Non-Muscle Invasive Bladder Cancer Treatment: A Systematic Review. Journal of Clinical Medicine. 2024; 13(13):3789. https://doi.org/10.3390/jcm13133789
Chicago/Turabian StyleChiujdea, Sever, Matteo Ferro, Mihai Dorin Vartolomei, Giuseppe Lucarelli, Kensuke Bekku, Akihiro Matsukawa, Mehdi Kardoust Parizi, Jakob Klemm, Ichiro Tsuboi, Tamas Fazekas, and et al. 2024. "Epirubicin and Non-Muscle Invasive Bladder Cancer Treatment: A Systematic Review" Journal of Clinical Medicine 13, no. 13: 3789. https://doi.org/10.3390/jcm13133789
APA StyleChiujdea, S., Ferro, M., Vartolomei, M. D., Lucarelli, G., Bekku, K., Matsukawa, A., Parizi, M. K., Klemm, J., Tsuboi, I., Fazekas, T., Mancon, S., & Shariat, S. F. (2024). Epirubicin and Non-Muscle Invasive Bladder Cancer Treatment: A Systematic Review. Journal of Clinical Medicine, 13(13), 3789. https://doi.org/10.3390/jcm13133789