For less aggressive recurrent disease, the chemotherapy options remain. Intravesical BCG can eradicate TCC in the prostatic urethra. 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. Overall 5-year survival was 78% in the no maintenance compared to 83% in the maintenance arm. with and without percutaneous administration. Introduction: Intravesical BCG immunotherapy and mitomycin C are considered as the standard treatment for non-muscle invasive bladder cancer. 20. 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. Long-term effecto of intravesical Bacillus Calmette-Guerin on flat The policy of withholding maintenance BCG from patients with increased side effects may have diminished the opportunity to observe severe toxicity. Important: Avoid contact with BCG vaccin… J Urol 144:658,1990. Alternatively, BCG can be given via ureteral catheters or intravesically, if reflux to the tumor site is confirmed. 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. Two BCG preparations are commercially available in the US: Connaught (TheraCys) and Tice (Organon) BCG. Maintenance BCG WARNING: Do not inject intravenously, subcutaneously, or intradermally. The preparation we now use has been modified (improved, we hope) from our original study based on subsequent research. Patients require coverage for gram negative sepsis as well until blood cultures are negative. Additional and Alternative Treatment Instillation of an immunotherapy drug (BCG) into the bladder for aggressive or frequently recurring non-muscle invasive cancer of the bladder. J Urol 147:4(242), 1992. Incidence and treatment, Lamm DL, Riggs D, Shriver J, VanGilder P, Rach J, DeHaven J: Megadose, Lamm DL, Morales A, Grossman HB, Lowe B, Swerdlow R, Ebert R, Habicht. Wait three months and have cystoscope. 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. 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. ____________________________________________________, 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 interferon in carcinoma in situ of the bladder. At each of these time points of BCG is instilled once a week for three weeks (i.e. Les premières évaluations de la BCG thérapie d'entretien datent du milieu des années 1980. For the latest published findings on maintenance therapy, see abstract below references. Lamm DL, Morales A, Grossman HB, Lowe B, Swerdlow R, Ebert R, Habicht Herr HW, Pinsky CM, Willet FW, Sogani PC, Oettgen HF and Melamed MR: 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. 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 68 151:21-26, 1994. 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. 6. 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. prone/ supine/ left lateral/ right lateral every 15 minutes for 1 hour Several studies have shown that BCG does reduce tumor progression as well. 135:265-70, 1986. Can be reconstituted via syringe method or using closed system administration supplies. /Length 5169 Wait three months and have cystoscope. An additional three weekly instillations can be given at three months, and followed with maintenance at 6 month intervals. At the next treatment interval (eg 6 months later), instillations should be initiated with log-lower BCG dose, 1/3, 1/10, or even 1/100th CFU BCG in 50cc preservative-free saline. 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). 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. These guidelines aim to describe the optimal condition to perform intravesical instillation of BCG or mitomycin C in order to increase its oncologic efficiency and to decrease its morbidity. 4. 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���� Progression was further significantly reduced(Lamm, J. Urol. instillation or intravesical therapy. Treatment protocols for bladder cancer are provided below, including those for chemotherapy, immunotherapy, and systemic neoadjuvant and adjuvant therapy. Wait three months and have cystoscope. All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival. 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). If irritative symptoms persist beyond three days, fail to respond to symptomatic treatment, or are severe isoniazid 300mg a day can be given. We expect to have mild to moderate irritative symptoms beginning after the second or third instillation. therapy can also be very effective in BCG failures (Nseyo). Below is the updated version of the BUI Bladder Instillations Protocol. BCG (Bacillus Calmette-Guérin) is a type of immunotherapy used in the treatment of bladder cancer. Prepare solution: Add 1 mL sterile water for injection to 1 ampul of vaccine. Follow with 3 weekly instillations (reduced dose as needed) at 6, 12, 18, 24 and 36 month. << Crisman, JE Montie, BA Lowe, MF Sarosdy, RD Bohl, HB Grossman, TM Beck, /Producer (pdfFactory Pro 3.51 \(Windows XP Professional French\)) 2. 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. If all clear, wait a week and begin sixth maintenance round of 3 weekly instillations (Month 30) BCG is not necessary unless tumor recurrence becomes a problem for these patients. 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. Symptoms should last no more than 2 days. Patients with CIS or Grade 3 TCC are at long-term risk for tumor recurrence in the bladder, lower ureters, and prostatic urethra. 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. J Urol Certaines des équipes qui utilisent la BCG thérapie d'entretien ont même changé de protocole au fil du temps. 4 0 obj endobj Both are highly effective and safe, when used carefully. 156:1934-41,1996), but unfortunately chemotherapy does not reduce stage progression. Since cultures are often negative, treatment must be given empirically. Glashan RW: A randomized controlled study of intravesical alpha-2b 2. 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. situ transitional cell carcinoma of the bladder: a multicenter phase �LJ*W~� ��j��C;L�u=W���|���[�����p��T[��Iy{�6��L[�[�? BCG maintenance therapy also reduced the incidence of other cancers, primarily prostate cancer. What is Bladder Instillation Therapy? Both of the Connaught BCG studies used percutaneous BCG. The optimal maintenance sc … Instillation of TICE BCG with an actively bleeding mucosa may promote systemic BCG infection. Herr HW, Pinsky CM, Willet FW, Sogani PC, Oettgen HF and Melamed MR: Hillyard RW Jr, Ladaga L, and Schellhammer PF, Superficial Transitional. In patients with diffuse or aggressive disease, consideration should be given to resection of the ureteral orifices to induce reflux. See package insert. This study was closed to accrual in 1987, so follow-up now exceeds 12 years. BCG INSTILLATION . update on the protocol: from Dr. Lamm’s site: It is also true that maintenance can cause side effects. In the SWOG study the rate of tumor recurrence increased one year after completion of maintenance therapy. If patients have no symptoms from BCG instillation, or if they have tumor recurrence, consider doing a PPD skin test. 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. Results: No toxicities above grade 3 were noted in the 243 maintenance arm patients. It's used to help keep the cancer from growing and to help keep it from coming back. 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. At the three month evaluation, 192 in each arm were disease free and therefore eligible for evaluation of the benefit of maintenance BCG. TUR will also increase the contact of BCG with the prostatic urethra. If disease progression occurs, or grade 3 disease is present after 6 months of BCG treatment, cystectomy is generally recommended.

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