BCG Full Course - Pro (16x9)
Transcript of BCG Full Course - Pro (16x9)
BCG Maintenance Full SWOG Course
Pro Argument
Erik P. Castle M.D., F.A.C.S.Professor of Urology
Mayo ClinicDepartment of Urology
Phoenix, AZ
• None
Financial Disclosures
Overview• Briefly review the SWOG �Full Course� that
is used
• What patients are we really talking about?
• What �really happens�?
• Why I think the full course is the way to go
Intravesical Therapy; BCG/Maintenance; Chemotherapy/BCG Combinations
• Definitions important to keep in mind
• BCG relapse: recurrence after a period of disease-free status
- 3 mos for papillary tumors 6 mos for CIS
- Early - <1year
- Intermediate – 1-2 years
- Late - > 2 years
• BCG Refractory: persistence of disease after adequate induction and one maintenance course of BCG
- Can also be after induction if progression of stage/grade
• BCG Intolerant: inability to tolerate at least one full course of induction BCG
Risk StratificationAt the time of each occurrence/recurrence, a clinician should assign a clinical stage and classify a patient accordingly as “low-,” “intermediate-,” or “high-risk.” (Moderate Recommendation; Evidence Strength: Grade C)
Risk StratificationAt the time of each occurrence/recurrence, a clinician should assign a clinical stage and classify a patient accordingly as “low-,” “intermediate-,” or “high-risk.” (Moderate Recommendation; Evidence Strength: Grade C)
Intravesical Therapy; BCG/Maintenance; Chemotherapy/BCG Combinations
In an intermediate-risk patient a clinician should consider administration of a six week course of induction intravesical chemotherapy or immunotherapy. (Moderate Recommendation; Evidence Strength: Grade B)
In a high-risk patient with newly diagnosed CIS, high-grade T1, or high-risk Ta urothelial carcinoma, a clinician should administer a six-week induction course of BCG. (Strong Recommendation; Evidence Strength: Grade B)
Intravesical Therapy; BCG/Maintenance; Chemotherapy/BCG Combinations
In an intermediate-risk patient who completely responds to induction BCG, a clinician should consider maintenance BCG for one year, as tolerated. (Moderate Recommendation; Evidence Strength: Grade C)
In a high-risk patient who completely responds to induction BCG, a clinician should continue maintenance BCG for three years, as tolerated. (Moderate Recommendation; Evidence Strength: Grade B)
SWOG Course
• Induction: 6 weeks- “connaught”
• Maintenance:- 3, 6, 12, 18, 24, 30, 36 months- Weekly for 3 weeks
SWOG Course
• Induction: 6 weeks- “connaught”
• Maintenance:- 3, 6, 12, 18, 24, 30, 36 months- Weekly for 3 weeks
SWOG Course• No maintenance:
- RFS - 35.7mos
• Maintenance:- RFS – 76.8 mos
• Further intervention not estimable• 5yr OS about the same
SWOG Course• No maintenance:
- RFS - 35.7mos
• Maintenance:- RFS – 76.8 mos
• Further intervention not estimable• 5yr OS about the same
Decreasing toxicity• Studies have looked at alternatives due to toxicity concerns
• Monthly maintenance as an option but only for 1 year
• Varying does such as the EORTC trial
• What is optimal?
Decreasing toxicity
• 37 Patients – prospective non-randomized• Monthly maintenance for 1 year only• TICE• Same criteria as 8507• f/u 40.7 mos• 2.7 % toxicity• 75.7% free of disease
Decreasing toxicity
• Patients randomized to 1 of 4 groups- 1/3D- 1yr- 1/3D -3 yr- FD 1 yr- FD 3 yr
• 1355 patients• Non-inferiority trial
Decreasing toxicity
• 1/3 D – 1 yr was suboptimal compared with FD 3-yr
• Intermediate risk patients – FD 1yr was equal to FD 3- yr
• High risk patients – Reduction in recurrence in FD 3-yr
Decreasing toxicity
Decreasing toxicity
• Conclusion:- “No differences in toxicity between 1/3D and FD. Intermediate risk patients
should be treated with FD-1yr. In high-risk patients, FD-3 yr reduces recurrences as compared with FD 1-yr but not progression or deaths. The benefit of the additional two years of maintenance should be weighed against its added cost and inconvenience.”
What do I use?• I tend to put a slight variation on the SWOG protocol
- 18 months of q 3 months of treatment if tolerated- Then every 6 months up to 3 years- Then discuss annual maintenance with the patient
• I use in all pTcis and pT1 cases for sure if possible
• HGpTa and others less frequently
• Basically, in the high-risk patients!!
What happens in the real world?
• Some patients miss a dose or more
• Some patients can�t tolerate
• Some patients have their own ideas of what they want to do
Conventional wisdom
• Really for cis and T1
• Need to get induction on board after appropriate resections and within about 3 to 4 weeks
• If a good response then that �immunomodulation� should be continued
Summary• What are your and what are the patient goals?
- If cancer control then you need to do the whole course- *If tolerated
• What is the harm?- �BCG-osis� - I honestly can�t remember the last case- Inconvenient
• As Nike said: �JUST DO IT�
Conventional wisdom• After 18 months with no recurrence does it
really matter?- YES
• Does it really decrease recurrences?- YES
• Does it matter if they have symptoms?- YES