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. 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. Technique of BCG Maintenance. 139:290-293, 1988. Lamm est le premier à avoir suggéré un bénéfice de ce traitement. 21. Lamm DL, Riggs D, Shriver J, VanGilder P, Rach J, DeHaven J: Megadose If irritative symptoms persist beyond three days, fail to respond to symptomatic treatment, or are severe isoniazid 300mg a day can be given. TUR will also increase the contact of BCG with the prostatic urethra. CFU for the . En 1985, cet auteur a rapporté qu'une instillation tous les 3 mois en plus du traiteme… BCG is a germ that's related to the one that causes tuberculosis (TB), but it doesn’t usually cause serious disease. I have had 3 treatment periods of BCG's. I begin with a superficial, circumferential resection of the prostatic urethra. Overall 5-year survival was 78% in the no maintenance compared to 83% in the maintenance arm. It is available over the counter, but generally has to be ordered by the pharmacy (800-531-3333). Prostatic Urethra: Results of Treatment With Intravesical Bacillus Photodynamic Single instillations have been demonstrated to be effective with Thiotepa, Adriamycin (50mg/50cc), Mitomycin (20mg/20cc), and Epirubicin, even in these “low risk” patients. 8. This study was closed to accrual in 1987, so follow-up now exceeds 12 years. In patients with CIS, Grade 3, or stage T1 disease I therefore recommend continuation of three week maintenance at years 4, 5, 6, 8, 10, and 12. BCG must be used within 2 hours of reconstitution. for transitional-cell carcinoma of the bladder. After 28 years of academic practice, Dr. Lamm has opened a private practice limited to genito-urinary oncology: Patients may be given Pyridium for dysuria, anticholinergics for frequency, and/or acetaminophen for pain. Then follow at 4, 5 and 6 years, and then 8, 10 and 12 years. TURBT      Cysto  x  x    x   x   x    x           x  x  x  x  x Cell Carcinoma of the Bladder Associated With Mucosa Involvement of the 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. 156:1934-41,1996), but unfortunately chemotherapy does not reduce stage progression. �w:k>4����׬��J�Y����4ϧY�;{��y��$9]NO�����������E#��Fx+)3�7&F�RF��y�ÿ��_��2Ƅ�����5��v��a������} r���{7�`tછ�~;KeL�s���0=���y���!N�ƾ#1���98mo��7iu��&��ˑw��ӗ��}����K�q�����]F Patients require coverage for gram negative sepsis as well until blood cultures are negative. BCG is relatively resistant to cycloserine and pyrazinamide. Our double blind comparison of recommended daily allowance vitamins versus high doses of vitamins A, C, B6, E, and zinc (Lamm, 1994) in BCG treated patients demonstrated a remarkable and highly significant 40% further reduction in tumor recurrence. Occasionally higher doses of prednisone are required. However, controversy remains regarding the role of maintenance therapy, and its long-term effect on recurrence and progression. Treatment protocols for bladder cancer are provided below, including those for chemotherapy, immunotherapy, and systemic neoadjuvant and adjuvant therapy. J. Urol. 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. Wait three months and have cystoscope. Several studies have shown that BCG does reduce tumor progression as well. 9. BCG pc. The most effective schedule would be BCG maintenance administered at months 3, 6, 12, 18, 24, 30, 36. If all clear, wait a week and begin third maintenance round of 3 weekly instillations (Month 12, or Year 1) ABSTRACT. 3 week maintenance is repeated at 6, 12, 18 and 24 months, and then at years 3, 4, 5 and 6 followed by … Prepare solution: Add 1 mL sterile water for injection to 1 ampul of vaccine. 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. The dose is two tablets twice a day (only three a day for persons under 100 lb). What is Bladder Instillation Therapy? 6. 1. 8. BCG therapy: at all times throughout this procedure a closed system must be maintained and PPE must be worn; administer as per institutional policy; clamp (if patient unable to retain medication) or remove IDC; post instillation some clinicians recommend rotating position e.g. Recurrence of TCC in the prostatic urethra is common, and in patients with CIS or high grade TCC must be carefully sought. The maintenance schedule also significantly reduced disease progression. 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 We would like to show you a description here but the site won’t allow us. with and without percutaneous administration. 13. Percutaneous BCG may need to be repeated if the skin test is negative (less than 5mm of induration). Current Recommendations for BCG Immunotherapy, Donald L. Lamm, MD. If patients have no symptoms from BCG instillation, or if they have tumor recurrence, consider doing a PPD skin test. Estimated median recurrence-free survival was 35.7 months (95% confidence interval 25.1 to 56.8) in the no maintenance and 76.8 months (64.3 to 93.2) in the maintenance arm (log rank p <0.0001). Randomized prospective comparison of intravesical Tice BCG immunotherapy The global shortages in TICE BCG … J Urol In my SWOG study of three week maintenance BCG, 14% of patients who had residual CIS at the three month evaluation went on to have complete response by the six month evaluation without further treatment. of maintenance versus nonmaintenance intravesical Bacillus After today's meeting w/ my Urologist, we talked about Tecentriq (just approved May 18, 2016) as replacement for BCG. 10. 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. instillation or intravesical therapy. Immunotherapy Your own body’s immune system cells switch on to Intravesical Immnuotherapy uses a live vaccine called Bacillus Calmette-Guerin (BCG), which is also used to inoculate against Tuberculosis; when this is placed in the bladder it creates a local inflammatory reaction that kills cancer cells. Following the standard 6 week induction course of BCG, patients have cystoscopy at three months. Immune stimulation may reduce the risk of cancer associated with age-related waning of immunity. 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. 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. 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. If all clear, wait a week and begin sixth maintenance round of 3 weekly instillations (Month 30) Upper urinary tract involvement in patients with bladder carcinoma in 19:591-600,1992. 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). Depuis 35 ans, ce cancer, fréquent dans les pays industrialisés, est en partie traité par le BCG, le vaccin contre la tuberculose. 3. BCG maintenance therapy also reduced the incidence of other cancers, primarily prostate cancer. 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. With sepsis the current treatment of choice is no longer cycloserine, but isoniazid, rifampin, and prednisone 40mg daily. Progression was further significantly reduced(Lamm, J. Urol. Urol., 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. Discard syringe with vial venting device. 9. 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. Badalament RA, Herr HW, Wong GY, et al. Urol Clin N Amer. 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. Lamm DL, Sardosdy MF, Grau DA, Buchanan J, Hunt J, and DeHaven J: I therefore recommend the three week maintenance schedule (see below). For the latest published findings on maintenance therapy, see abstract below references. The optimal maintenance sc … /Producer (pdfFactory Pro 3.51 \(Windows XP Professional French\)) 4 0 obj Additional and Alternative Treatment Excess BCG administration is associated with increased side effects and suppression of antitumor immune response. BCG reduces disease progression compared with surgery or surgery plus chemotherapy, and maintenance BCG results in a further significant reduction in progression. 16. 147, 738-742, 1992. Lamm DL, Blumenstein BA, Crawford ED, et al: A randomized trial of Induction round of six weekly instillations. 11. Herr HW, Pinsky CM, Willet FW, Sogani PC, Oettgen HF and Melamed MR: Hillyard RW Jr, Ladaga L, and Schellhammer PF, Superficial Transitional. 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). We have had a favorable experience with KLH (48% CR, Lamm,1996), and have an ongoing clinical trial. With serious infections triple antibiotic therapy may be needed, and ethambutol 1200mg daily or a fluoroquinolone may be added. Estimated median time for worsening-free survival, defined as no evidence of progression including pathological stage T2 disease or greater, or the use of cystectomy, systemic chemotherapy or radiation therapy, was 111.5 months in the no maintenance and not estimable in the maintenance arm (log rank p = 0.04). Lamm DL, Crawford ED, Blumenstein B, Crissman JD, Montie J, Gottesman J, Lamm DL, Meijden APM van der, Morales A, et al. See package insert. Treatment should be postponed for at least one week following transurethral resection, biopsy, x situ (TIS): Its impact on management. For patients with renal pelvic or upper ureteral TCC who are not candidates for nephroureterectomy, BCG can be given through a percutaneous nephrostomy tube. In our SWOG study 660 patients received induction BCG and 550 were randomized to observation vs maintenance BCG. Notably, the reduction in the incidence of prostate cancer was greater than the reduction in other malignancies: 14 of 179 men (6.9%) in the induction arm versus 5 of 151 (3.3%) in the maintenance arm. On May 5, 1999, Donald Lamm, MD, discussed a study recently completed by the Soutwest Oncology Group (SWOG) at the American Urological Association meeting in Dallas. Side effects of intravesical therapies. In my comparison TICE BCG using a monthly maintenance schedule with mitomycin C, 55% had complete response vs 44% CR with mitomycin (Urol. Since cultures are often negative, treatment must be given empirically. Bladder Cancer, Genitourinary Oncology; BCG Oncology, P.C. << • Transfer appropriate amount of BCG directly into 50 cc vial of PBS/Intron A. Wait three months and have cystoscope. %PDF-1.4 7. Divers protocoles d'entretien par le BCG ont été testés, mais aucun n'a été retenu comme protocole de référence. Following the six month cystoscopy, an additional three weekly instillations are given. Then follow at 4, 5 and 6 years, and then 8, 10 and 12 years. Use a condom between treatments and for six weeks following your final treatment. 17. 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). Treatment involves placing a … 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. Though a major component of this reaction is hypersensitivity, prednisone alone without isoniazid and rifampin should not be given. At each of these time points of BCG is instilled once a week for three weeks (i.e. For less aggressive recurrent disease, the chemotherapy options remain. If all clear, wait a week and begin fifth maintenance round of 3 weekly instillations (Month 24, or Year 2) Incidence and treatment 4. JT Leimert, ED Crawford, U Kosecka, and R Wittes. In case of BCG shortage: i. 19. Do not use a filter with BCG instillation. 1 0 obj Of 307 patients, 25% developed upper tract tumor (median 56 months) and 32% of relapses were fatal. A prospective randomized trial 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. J Urol. BCG is administered directly into the bladder via a catheter. However, these results with a lower level of evidence should be treated with caution. A single percutaneous treatment at the start of treatment should suffice. Dr. Lamm reported that three-week maintenance therapy with BCG vaccine (Calmette-Guerin bacillus) in 385 subjects increased complete response in pre-invasive bladder cancer from 70 percent to 84 percent and reduced recurrence from 52 percent to 25 percent at eight years. 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. 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���� Symptoms should last no more than 2 days. For a print-friendly version of this material, click here. It's used to help keep the cancer from growing and to help keep it from coming back. J Urol 144:658,1990. Simple explanation of Dr. Lamm’s protocol Long-term effecto of intravesical Bacillus Calmette-Guerin on flat BCG INSTILLATION . 7. 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. BCG immunotherapy can be more toxic than Mitomycin chemotherapy. 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. Can be reconstituted via syringe method or using closed system administration supplies. J Urol. << of complications of Bacillus Calmette-Guérin intravesical therapy in Median recurrence-free survival time was twice as long in the 3-week maintenance arm compared to the no maintenance arm, and patients had significantly longer worsening-free survival. The results of induction BCG were excellent, and very similar to our experience and that of others with BCG immunotherapy: only 52% of patients developed tumor recurrence. Two BCG preparations are commercially available in the US: Connaught (TheraCys) and Tice (Organon) BCG. Le BCG : un traitement efficace dans le cancer de la vessie Limiter les rechutes dans le cancer de la vessie, voici l'enjeu d'une étude dirigée par l'équipe de Matthew Albert à l'Institut Pasteur. Wait three months and have cystoscope. Alternatively, BCG can be given via ureteral catheters or intravesically, if reflux to the tumor site is confirmed. 139:300A (550), Three months following initiation of BCG induction therapy 550 consenting patients were stratified by purified protein derivative skin test and the presence of carcinoma in situ, and then randomized by central computer to receive BCG maintenance therapy (maintenance arm) or no BCG maintenance therapy (no maintenance arm). 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. interferon in carcinoma in situ of the bladder. ҙB���Q�ya,0b��>�;&�E֧���M�|�>�a����������{�|�uׄ�u�u6!�ݧ\�����. Therefore, the most important time for evaluation in BCG treated patients is at 6 months. Recurring use of BCG increases the likelihood of more severe side effects like greater bladder irritation and inflammation and a burning feeling in the bladder and … Wait three months and have cystoscope. BCG is not necessary unless tumor recurrence becomes a problem for these patients. 14. /Title (5 - Instillation BCG.pub) 3. We expect to have mild to moderate irritative symptoms beginning after the second or third instillation. If all clear, wait a week and begin second maintenance round of 3 weekly instillations (Month 6) Study. Both are highly effective and safe, when used carefully. Follow with 3 weekly instillations (reduced dose as needed) at 6, 12, 18, 24 and 36 month. If symptoms are more severe or prolonged, isoniazid 300mg daily can be used to treat the symptoms. RESULTS: Seventy of the 35 randomized, evaluable patients developed The same dose of BCG is given in 50cc of saline and infused over 2 hours. 1. The policy of withholding maintenance BCG from patients with increased side effects may have diminished the opportunity to observe severe toxicity. CANCER. 8. prone/ supine/ left lateral/ right lateral every 15 minutes for 1 hour The preparation, called “Oncovite,” is made by Mission Pharmacal. Intravesical chemotherapy reduces short-term (2 year) tumor recurrence by 20% or less when compared to surgery alone. 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. If all remains clear, continue with maintenance rounds of 3 weekly instillations at years 4, 5, 6, 8, and 10. However, more than 90% of healthy adults will convert to a positive PPD skin test with percutaneous BCG, and a positive PPD increases the complete response in CIS from 49% to 77% (P<0.0001). Wait three months and have cystoscope. Important: Avoid contact with BCG vaccin… Lamm DL, Crawford ED, Blumenstein B, Crissman JD, Montie J, Gottesman J, Both of the Connaught BCG studies used percutaneous BCG. Les premières évaluations de la BCG thérapie d'entretien datent du milieu des années 1980. J Clin Oncol. Maintenance BCG Nothing is lost by postponing BCG treatment if patients have symptoms, because symptoms are evidence of continued immune stimulation. 155:622A(1405), 1996. In our animal model, prednisone alone increased mortality, but prednisone plus antibiotics markedly improved survival when compared with antibiotics alone. 1991;325:1205. Caution must be taken to taper the prednisone slowly because hypotension may return when prednisone is stopped. malignancy other that TCC during the 8 year follow-up: 46/202 (23%) in My randomized comparison of intravesical with or without percutaneous TICE BCG administration (J Urol 145:738, 1991) showed no added benefit of percutaneous BCG. DeHaven JI, Traynellis CT, Riggs DR, and Lamm DL: Antibiotic and Steroid A prospective randomized trial, DeHaven JI, Traynellis CT, Riggs DR, and Lamm DL: Antibiotic and Steroid, Glashan RW: A randomized controlled study of intravesical alpha-2b. 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. In patients with diffuse or aggressive disease, consideration should be given to resection of the ureteral orifices to induce reflux. The prostatic urethra should be biopsied. Therefore, our next study will use percutaneous BCG. We now recommend supplemental vitamins for bladder cancer patients. therapy can also be very effective in BCG failures (Nseyo). Glashan RW: A randomized controlled study of intravesical alpha-2b Patients with a solitary papillary tumor that appears to be low grade can be best treated with single instillation of chemotherapy (Thiotepa 30mg/30cc water for 30 minutes, for example) at the conclusion of the resection. With three additional BCG instillations at 3 months, the complete response per cent increased by 30% at 6 months. 1988. 3. 20. vitamins in bladder cancer: A double-blind clinical trial. The three week course of BCG is then repeated at 12, 18, 24, 30, and 36 months. 6. Lowe B, Sarosdy MF, Bohl RD, Weems WL, Grossman HB, Smith JA, Beck TM, Instillation of TICE BCG with an actively bleeding mucosa may promote systemic BCG infection. Thanks to Crilly Butler for the above summary, back to non-muscle-invasive bladder cancer, Badalament RA, Herr HW, Wong GY, et al. Draw into syringe and expel back into ampul 3 times to mix. BCG sepsis can be fatal, and prompt and effective treatment is necessary. 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. All 4 CIS patients responded to combination therapy but 5 of 16 CIS patients treated with BCG alone did not. Oncol. There is no need to repeat cystoscopy until at least 4-6 weeks after completion of the 6-week induction course. K: Keyhole-limpet hemocyanin (KLH) immunotherapy of papillary and in Key Points • This involves having a catheter (plastic tube) passed into your bladder to instil an anti-cancer drug called BCG • BCG is a vaccine that is used against tuberculosis; it contains live If patients respond promptly, I generally stop treatment after only one or two weeks. Wait three months and have cystoscope. 16:1099,1998). Vol. Women should avoid getting pregnant or breastfeeding while on BCG therapy. Calmette-Guérin; J. Urol. Patients with CIS or Grade 3 TCC are at long-term risk for tumor recurrence in the bladder, lower ureters, and prostatic urethra. endobj About two weeks after resection 81mg of Connaught BCG (TheraCys) or 50mg of TICE BCG in 50cc sterile normal saline can be instilled via a small catheter. 4. Long-term (5-8 year) recurrence is reduced by 7% (Pawinsky A , EORTC/MRC: J Urol. While BCG has been compared to single agent intravesical chemotherapy as first-line therapy, few studies exist comparing BCG to sequential intravesical chemotherapy regimens. Thereafter they leave the office and are asked to retain the suspension, if possible, for two hours. Intravesical BCG can eradicate TCC in the prostatic urethra. (Month 0) In patients with no disease or recurrence of disease without progression, three weekly instillations of BCG are given one week after cystoscopy. For a print-friendly version of the following material, click here, A simplified summary of the protocol is also found below Never give BCG if symptoms from previous BCG administrations are still present, and never instill BCG if the catheterization is traumatic or bloody. 2. Valstar (800 mg) has been recently approved for CIS patients who fail BCG and are not candidates for cystectomy. intravesical doxorubicin and immunotherapy with Bacille Calmette-Guérin J Urol. A SOUTHWEST ONCOLOGY GROUP STUDY. BCG (Bacillus Calmette-Guérin) is a type of immunotherapy used in the treatment of bladder cancer. /Filter/FlateDecode Lamm DL, Meijden APM van der, Morales A, et al. 1987;5:441. Instillation Directions • Insert instillation spike with attached tubing and closed pinch clamp into top of PBS vial. The preparation we now use has been modified (improved, we hope) from our original study based on subsequent research. Herr HW, Pinsky CM, Willet FW, Sogani PC, Oettgen HF and Melamed MR: In the SWOG study the rate of tumor recurrence increased one year after completion of maintenance therapy. I-II clinical trial. Wait three months and have cystoscope. If all clear, wait a week and begin seventh maintenance round of 3 weekly instillations (Month 36, or Year 3) 16620 N. 40th St. Suite E, Phoenix AZ 85032 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. carcinoma in situ of the bladder. 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. BCG treatment for non-invasive bladder cancer BUI Protocol. I generally give a “6 plus 3” course, confirm response with cytology and a nephrostogram, and then pull the nephrostomy tube. 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. 151:21-26, 1994. Intravesical therapy does not eradicate TCC of the distal ureters, and upper tract TCC is most likely to occur in patients with CIS of the bladder. Patients with CIS, Grade 3 TCC, or lamina propria invasion are best treated with BCG. Avoid exposing BCG to direct sunlight. /Author (tbaril) All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival. Of 251 men, 24% developed TCC of the prostatic urethra (median 11 months), and 44% or these relapses were fatal. {niftybox width=180px,float=right,textalign=left}. Interferon has a 47% complete response rate in CIS, and we have seen long term responses and responses after BCG failure (Glashan).
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