BCG Full Course - Pro (16x9)

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BCG Maintenance Full SWOG Course Pro Argument Erik P. Castle M.D., F.A.C.S. Professor of Urology Mayo Clinic Department of Urology Phoenix, AZ

Transcript of BCG Full Course - Pro (16x9)

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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

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• None

Financial Disclosures

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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

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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

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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)

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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)

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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)

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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)

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SWOG Course

• Induction: 6 weeks- “connaught”

• Maintenance:- 3, 6, 12, 18, 24, 30, 36 months- Weekly for 3 weeks

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SWOG Course

• Induction: 6 weeks- “connaught”

• Maintenance:- 3, 6, 12, 18, 24, 30, 36 months- Weekly for 3 weeks

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SWOG Course• No maintenance:

- RFS - 35.7mos

• Maintenance:- RFS – 76.8 mos

• Further intervention not estimable• 5yr OS about the same

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SWOG Course• No maintenance:

- RFS - 35.7mos

• Maintenance:- RFS – 76.8 mos

• Further intervention not estimable• 5yr OS about the same

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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?

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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

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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

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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

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Decreasing toxicity

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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.”

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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!!

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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

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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

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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�

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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