The criteria for increased risk were 2 or more episodes of tumor within the most recent year, or 3 or more tumors within 6 months. 3. Then follow at 4, 5 and 6 years, and then 8, 10 and 12 years. En 1985, cet auteur a rapporté qu'une instillation tous les 3 mois en plus du traiteme… Thereafter they leave the office and are asked to retain the suspension, if possible, for two hours. Patients with CIS or Grade 3 TCC are at long-term risk for tumor recurrence in the bladder, lower ureters, and prostatic urethra. 135:265-70, 1986. With serious infections triple antibiotic therapy may be needed, and ethambutol 1200mg daily or a fluoroquinolone may be added. BCG immunotherapy can be more toxic than Mitomycin chemotherapy. Lowe B, Sarosdy MF, Bohl RD, Weems WL, Grossman HB, Smith JA, Beck TM, Draw into syringe and expel back into ampul 3 times to mix. J Urol. We now recommend supplemental vitamins for bladder cancer patients. Instillation Directions • Insert instillation spike with attached tubing and closed pinch clamp into top of PBS vial. Wait three months and have cystoscope. bladder cancer: a randomized prospective Southwest Oncology Group Interferon has a 47% complete response rate in CIS, and we have seen long term responses and responses after BCG failure (Glashan). Urol Clin N Amer. For the latest published findings on maintenance therapy, see abstract below references. Therefore, I recommend annual cystoscopic examination under anesthesia, with upper tract washes and retrogrades (followed by ureteroscopy if the retrograde shows anything) in these patients. Patients require coverage for gram negative sepsis as well until blood cultures are negative. In patients who have true BCG infection requiring antituberculous antibiotics, for example symptomatic prostatitis, epididymitis, or hepatitis, isoniazid plus rifampin 600mg daily should be given for 3-6 months. These patients can be safely treated in the office. METHODS: To test the hypothesis that maintenance BCG immunotherapy might protect against the development of other malignancies as well as reduce bladder tumor recurrence, the incidence of other malignancies in patients enrolled in SWOG 8507 was recorded. /Title (5 - Instillation BCG.pub) The same dose of BCG is given in 50cc of saline and infused over 2 hours. J Urol In patients with CIS treated with BCG, the incidence of TCC in the upper ureter is likely to be higher than the 25% reported by Herr in his combined series that included patients without CIS. BCG instillation as per protocol Date instillation given Usual medications Assess for analgesia requirements 6 Diet & Hydration Usual diet and fluids Usual diet Encourage oral fluids after treatment 7 Hygiene Education provided on Chlorhex wash Pre procedure genital Chlorhex wash 8 Elimination & Safety Patient educated on safe voiding H��W[sݶv~��[�3D\I��Ķ2�x�:�I_��H��Twi'n~}A�����3�hF6(`�׷��ȯ����_���w'��{�h+��we�tBS��M�;A{9��(�͉S.��k�qrָ���\�3���� instillation or intravesical therapy. Unused solution is discarded as biohazardous waste after 2 hours. Purpose: Bacillus Calmette-Guerin (BCG) immunotherapy has been widely accepted as the optimal treatment for carcinoma in situ and high grade superficial transitional cell carcinoma. endobj The dose for the intravesical treatment of BCG is one vial suspended in 50 mL preservative free saline (0.9% Sodium Chloride Injection U.S.P). The dose is two tablets twice a day (only three a day for persons under 100 lb). The policy of withholding maintenance BCG from patients with increased side effects may have diminished the opportunity to observe severe toxicity. /Creator (pdfFactory Pro www.fineprint.fr) 1. DeHaven JI, Traynellis CT, Riggs DR, and Lamm DL: Antibiotic and Steroid Lamm DL, Meijden APM van der, Morales A, et al. 17. The local immune response is considered to be of primary importance in BCG immunotherapy, and up to 75% of men develop granuloma in the prostate following intravesical BCG. Solsona et al reported TCC in the distal ureter in 25% of 138 patients with CIS treated with cystectomy compared with 2.3% of 786 patients with superficial bladder cancer and 2.9% of 179 patients with invasive disease (Solsona, 1997). Wait three months and have cystoscope. tel: 602 493 6626. 20. BCG immunotherapy using 6 week induction, monthly maintenance for one year, single quarterly maintenance for two years, repeat 6 week instillation, or even 6 week instillations for 2 years reduces tumor recurrence by about 40% short-term and 20% long-term. 1 0 obj 2. A prospective randomized trial In patients who received maintenance BCG, only 25% had recurrence, or 27% fewer than induction BCG (P<0.000001, and 45% and 52% fewer than expected with chemotherapy or surgery alone). Badalament RA, Herr HW, Wong GY, et al. Treatment should be postponed for at least one week following transurethral resection, biopsy, Additional and Alternative Treatment Never give BCG if symptoms from previous BCG administrations are still present, and never instill BCG if the catheterization is traumatic or bloody. If disease progression occurs, or grade 3 disease is present after 6 months of BCG treatment, cystectomy is generally recommended. J Urol 147:4(242), 1992. If all clear, wait a week and begin fourth maintenance round of 3 weekly instillations (Month 18) BCG has been proven to be superior to chemotherapy (Thiotepa, Adriamycin, Mitomycin, and Epirubicin) in comparative controlled studies and BCG, but not chemotherapy, is found to significantly reduce disease progression. For a print-friendly version of this material, click here. Though a major component of this reaction is hypersensitivity, prednisone alone without isoniazid and rifampin should not be given. Following the standard 6 week induction course of BCG, patients have cystoscopy at three months. Week 2 Month 3   6  12  18  24  30 Year  3  4  5  6  8  10  12 >> Unlike cytotoxic chemotherapy, which kills cells by direct contact, BCG kills cells by inducing an immune response. 16620 N. 40th St. Suite E, Phoenix AZ 85032 For a print-friendly version of the following material, click here, A simplified summary of the protocol is also found below carcinoma in situ of the bladder. Instillation of an immunotherapy drug (BCG) into the bladder for aggressive or frequently recurring non-muscle invasive cancer of the bladder. 469 Background: Bacillus Calmette-Guerin (BCG) is the standard of care for patients with new non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. This is an outpatient procedure during which a tube (catheter) is first inserted into the bladder, and a medication is infused through so that it can coat the inside of the bladder for a short time. %PDF-1.4 Can be reconstituted via syringe method or using closed system administration supplies. week 1 - 6 Induction BCG; week 12 Rigid cystoscopy after induction; week 14 - 16 Maintenance course 1; week 22 Flexible cystoscopy 1 Of 307 patients, 25% developed upper tract tumor (median 56 months) and 32% of relapses were fatal. BCG Bladder Instillation Instructions EXPLANATION: BCG is a solution made of the tubercular bacillus developed in such a way that it can be used in the treatment of bladder tumors. At each of these time points of BCG is instilled once a week for three weeks (i.e. for transitional-cell carcinoma of the bladder. Overall, the recurrence rates for full-dose BCG, one-third dose BCG and one-third dose BCG plus interferon were 50%, 30% and 10% (Pearson’s test, p~O.O3S). BCG treatment for non-invasive bladder cancer BUI Protocol. Immunotherapy Your own body’s immune system cells switch on to Nothing is lost by postponing BCG treatment if patients have symptoms, because symptoms are evidence of continued immune stimulation. therapy can also be very effective in BCG failures (Nseyo). 4. Materials and Methods: All patients in the study had transitional cell carcinoma of the bladder with carcinoma in situ or an increased risk of recurrence. Crisman, JE Montie, BA Lowe, MF Sarosdy, RD Bohl, HB Grossman, TM Beck, For less aggressive recurrent disease, the chemotherapy options remain. Patients with CIS, Grade 3 TCC, or lamina propria invasion are best treated with BCG. 1/3 dose BCG weekly for up to 3 weeks beginning at 3 months (that would be 6 weeks after the 6 week induction). (Month 0) Urol., Thus, strict adherence to the protocol for canceling the BCG in the presence of infection, and aborting the instillation in the setting of trauma and/or any degree of gross hematuria, is required. 8. Divers protocoles d'entretien par le BCG ont été testés, mais aucun n'a été retenu comme protocole de référence. Antitubercular antibiotics are infrequently necessary. Instruct to keep vaccination site dry for 24 h; no dressing is needed. BCG pc. It is available over the counter, but generally has to be ordered by the pharmacy (800-531-3333). 11. Use a condom between treatments and for six weeks following your final treatment. If all clear, wait a week and begin third maintenance round of 3 weekly instillations (Month 12, or Year 1) ____________________________________________________, MAINTENANCE BACILLUS CALMETTE-GUERIN IMMUNOTHERAPY FOR RECURRENT TA, T1 AND CARCINOMA IN SITU TRANSITIONAL CELL CARCINOMA OF THE BLADDER: A RANDOMIZED SOUTHWEST ONCOLOGY GROUP STUDY, DONALD L. LAMM*†; BRENT A. BLUMENSTEIN; JOHN D. CRISSMAN; JAMES E. MONTIE; JAMES E. GOTTESMAN; BRUCE A. LOWE; MICHAEL F. SAROSDY‡; ROBERT D. BOHL; H. BARTON GROSSMAN§; THOMAS M. BECK; JOSEPH T. LEIMERT; E. DAVID CRAWFORD||, From the West Virginia University Medical Center, Morgantown, West Virginia, Southwest Oncology Group Statistical Center and Swedish Hospital Tumor Institute, Seattle, Washington, Harper Hospital, Detroit and University of Michigan Medical Center, Ann Arbor, Michigan, Oregon Health Sciences University and Northwest Clinical Oncology Program, Portland, Oregon, University of Texas Health Science Center at San Antonio, San Antonio and University of Texas M. D. Anderson Cancer Center, Houston, Texas, Columbus Clinical Oncology Program, Columbus, Ohio, St. Luke’s Regional Medical Center, Boise, Idaho, and University of Colorado, Denver, Colorado THE JOURNAL OF UROLOGY 2000;163:1124-1129 Online at http://www.jurology.com April 2000, p. 1124 Excess BCG administration is associated with increased side effects and suppression of antitumor immune response. 3. To decrease the chance of pyelovenous backflow, a manometer is used in a manner analogous to Renacidin irrigation. Then follow at 4, 5 and 6 years, and then 8, 10 and 12 years. 19:591-600,1992. Results: No toxicities above grade 3 were noted in the 243 maintenance arm patients. All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival. 14.4 Management options for side effects associated with intravesical BCG 57 14.5 EORTC Quality of Life questionnaires 59 14.6 Example of Competency document 62 14.7 Example of Training document 63 14.8 Examples of Documentation for MMC and BCG instillation 66 14.9 Example of Side effect questionnaire 68 If patients respond promptly, I generally stop treatment after only one or two weeks. I then do a second circumferential resection and send this specimen as “margin.” The results of BCG immunotherapy are excellent if there is no invasive TCC in the margin. 9. In our animal model, prednisone alone increased mortality, but prednisone plus antibiotics markedly improved survival when compared with antibiotics alone. Based on previous reports, one would expect that 70% or more of patients treated with chemotherapy and 77% of patients treated with surgery alone would have had recurrence. • Transfer appropriate amount of BCG directly into 50 cc vial of PBS/Intron A. The prostatic urethra should be biopsied. /Length 5169 When patients begin to have increased symptoms following BCG instillation, the dose can be reduced to 1/3, 1/10, or 1/100th as needed to prevent significant side effects with subsequent treatment. Symptoms should last no more than 2 days. BCG is administered directly into the bladder via a catheter. The table on the next page shows the schedule of BCG … Consideration should also be given to transurethral resection of the prostate in these patients to reduce the risk of occult TCC in the prostatic ducts progressing to invasive disease. CIS of the lower ureters can be managed by resection of the anterior wall of the intramural ureter over an indwelling stent to induce reflux. I have had 3 treatment periods of BCG's. of maintenance versus nonmaintenance intravesical Bacillus However, controversy remains regarding the role of maintenance therapy, and its long-term effect on recurrence and progression. 6. OncoTICE BCG 12.5mg per vial containing 2-8 x 10 8 CFU Tice BCG.. After reconstitution in 50 ml saline the suspension contains 0.4-1.6 x 10 7 CFU/ml.. OncoTICE is a freeze-dried preparation containing attenuated bacilli of Mycobacterium bovis, prepared from a culture of Bacillus Calmette-Guérin (BCG). of complications of Bacillus Calmette-Guérin intravesical therapy in Overall 5-year survival was 78% in the no maintenance compared to 83% in the maintenance arm. Oncol. BCG is a germ that's related to the one that causes tuberculosis (TB), but it doesn’t usually cause serious disease. bleeding) • Active infective cystitis • Persistent gross haematuria • Resection of bladder tumour within 2 weeks I have patients lie on their abdomen for 15 minutes in the office to displace the anterior bubble that enters the bladder as the air is displaced from the catheter. Calmette-Guérin therapy of superficial bladder cancer. If all clear, wait a week and begin second maintenance round of 3 weekly instillations (Month 6) Introduction: Intravesical BCG immunotherapy and mitomycin C are considered as the standard treatment for non-muscle invasive bladder cancer. Lamm DL, Blumenstein BA, Crawford ED, et al: A randomized trial of Follow with 3 weekly instillations (reduced dose as needed) at 6, 12, 18, 24 and 36 month. [���M�ݐ�F�ܑ� #���0�3��d�;�5�S� Several studies have shown that BCG does reduce tumor progression as well. The most effective schedule would be BCG maintenance administered at months 3, 6, 12, 18, 24, 30, 36. prone/ supine/ left lateral/ right lateral every 15 minutes for 1 hour ҙB���Q�ya,0b��>�;&�E֧���M�|�>�a����������{�|�uׄ�u�u6!�ݧ\�����. J Urol. In case of BCG shortage: i. Wait three months and have cystoscope. Wait three months and have cystoscope. Only one of these five had advanced stage carcinoma of the prostate (Stage C) compared with six (43%, 3 stage C, 3 stage D) patients in the induction arm (RR 0.4, P=0.04). For patients with renal pelvic or upper ureteral TCC who are not candidates for nephroureterectomy, BCG can be given through a percutaneous nephrostomy tube. The preparation we now use has been modified (improved, we hope) from our original study based on subsequent research. The dose amount expressed in milligrams varies according to the BCG substrain; the typical dose of BCG used for intravesical instillation is 1-8 x 10. Herr HW, Pinsky CM, Willet FW, Sogani PC, Oettgen HF and Melamed MR: Nseyo, UO: Photodynamic Therapy. We would like to show you a description here but the site won’t allow us. The most commonly used agents are BCG (Bacillus Calmette-Guérin) and Mitomycin C. It is theorised that BCG stimulates an inflammatory response that promotes malignant cell kill by immunocompetent cells. Lamm DL, Riggs D, Shriver J, VanGilder P, Rach J, DeHaven J: Megadose N Engl J Med. J Clin Oncol. Solsona E, Iborra I, Rirus JV, Dumont R, Casanova JL, and Calabuig C: 1/3 dose BCG weekly for up to 3 weeks beginning at 3 months (that would be 6 weeks after the 6 week induction). K: Keyhole-limpet hemocyanin (KLH) immunotherapy of papillary and in BCG reduces disease progression compared with surgery or surgery plus chemotherapy, and maintenance BCG results in a further significant reduction in progression. Wait three months and have cystoscope. This study was closed to accrual in 1987, so follow-up now exceeds 12 years. It's used to help keep the cancer from growing and to help keep it from coming back. ABOUT BCG. 139:290-293, 1988. I therefore recommend the three week maintenance schedule (see below). RESULTS: Seventy of the 35 randomized, evaluable patients developed In patients with diffuse or aggressive disease, consideration should be given to resection of the ureteral orifices to induce reflux. In my study comparing Connaught BCG vs doxorubicin (New Engl J Med 25:1205, 1991) using 6 week induction and single maintenance instillations every 3 months for two years, complete response was seen in 70% of patients with CIS vs 34% with doxorubicin, and 48% vs 18% of patients remained disease free 5 years. Common side effects of BCG include flu-like symptoms, fatigue, fever, chills, or bladder irritation. Avoid exposing BCG to direct sunlight. Therefore, our next study will use percutaneous BCG. << Calmette-Guérin; J. Urol. Urology 49:347-352, 1997. Mitomycin C, on the other hand, inhibits the synthesis of DNA. There is no need to repeat cystoscopy until at least 4-6 weeks after completion of the 6-week induction course. Patients may be given Pyridium for dysuria, anticholinergics for frequency, and/or acetaminophen for pain. See package insert. At least 1 week following biopsy of carcinoma in situ and resection of any stage Ta or T1 transitional cell tumors 660 patients were started on a 6-week induction course of intravesical and percutaneous Connaught BCG. This specimen is collected and sent separately to pathology. The 384 eligible patients who were disease-free at randomization constitute the primary intent to treat analytic group because they could be followed for disease recurrence. Wait three months and have cystoscope. Conclusions: Compared to standard induction therapy maintenance BCG immunotherapy was beneficial in patients with carcinoma in situ and select patients with Ta, T1 bladder cancer. Vol. Discard syringe with vial venting device. Lamm DL, Crawford ED, Blumenstein B, Crissman JD, Montie J, Gottesman J, 16. Induction BCG followed by maintenance BCG instillation after TUR, compared with induction BCG along, can reduce the risk ratios of tumor recurrence and tumor progression, and prolong RFS. intravesical doxorubicin and immunotherapy with Bacille Calmette-Guérin It takes 6 weeks for the optimal immune response to develop in most patients when given the initial course of BCG. The preparation of BCG suspension must be done using aseptic technique. 155:622A(1405), 1996. Intravesical BCG should not be given within one week of bladder tumor resection. Since cultures are often negative, treatment must be given empirically. Administer instillation into bladder via catheter (dwell time of 1-2 hours) *This is a single dose given in operating room or within 24 hours of transurethral bladder tumour resection. All 4 CIS patients responded to combination therapy but 5 of 16 CIS patients treated with BCG alone did not. {/niftybox} 9. Wait three months and have cystoscope. Intravesical BCG can eradicate TCC in the prostatic urethra. 4 0 obj At the three month evaluation, 192 in each arm were disease free and therefore eligible for evaluation of the benefit of maintenance BCG. However, these results with a lower level of evidence should be treated with caution. Caution must be taken to taper the prednisone slowly because hypotension may return when prednisone is stopped. Maintenance BCG (once a week for 3 weeks) is begun at 3 months using 1/3 dose BCG, unless no side effects were noted during induction. BCG is not necessary unless tumor recurrence becomes a problem for these patients. Both are highly effective and safe, when used carefully. 1992;147:596. MAINTENANCE BCG IMMUNOTHERAPY: EVIDENCE OF ADDITIONAL PROTECTION AGAINST 19. After confirming reflux with a cystogram, intravesical BCG can then be used to treat the lower ureters. 1. Administer drug by dropping 0.2–0.3 mL onto clean surface of skin; then use a sterile multiple-puncture disk to create percutaneous skin punctures. Treatment protocols for bladder cancer are provided below, including those for chemotherapy, immunotherapy, and systemic neoadjuvant and adjuvant therapy. Simply stated, BCG reduces long-term recurrence by 20% compared to chemotherapy, and maintenance BCG reduces long-term recurrence by 25% relative to standard BCG. In my comparison TICE BCG using a monthly maintenance schedule with mitomycin C, 55% had complete response vs 44% CR with mitomycin (Urol. /CreationDate (D:20120911131858+02'00') Bacillus Calmette-Guerin or BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer. 7. There are two different types of medications that can be used: 1. That is why we always reduce the dose (1/3, 1/10, 1/100th even if needed) or hold treatment if increasing side effects are seen. BCG is relatively resistant to cycloserine and pyrazinamide. Wait three months and have cystoscope. Lamm DL, Sardosdy MF, Grau DA, Buchanan J, Hunt J, and DeHaven J: Lamm DL, Blumenstein BA, Crawford ED, et al: A randomized trial of. CANCER. Introduction: Three-week maintenance BCG, when compared to standard 6-week induction, increases complete response in CIS from 70% to 84%, reduces recurrence of Ta, T1 TCC from 52% to 25% at 8 years, and significantly reduces disease progression/worsening. 8. 10. Photodynamic Treatment involves placing a … Current Recommendations for BCG Immunotherapy, Donald L. Lamm, MD. with and without percutaneous administration. {niftybox width=180px,float=right,textalign=left}. Below is the updated version of the BUI Bladder Instillations Protocol. An additional three weekly instillations can be given at three months, and followed with maintenance at 6 month intervals.
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