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Chemotherapy for Bladder Cancer

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CMV

Vinblastine 3 mg/m2 IVB days 1 & 8
Methotrexate 30 mg/m2 IVB days 1 & 8
Cisplatin 100 mg/m2 IV/4h day 2

Repeat cycle every 21 days.

Ref: Harker WG, et al: J Clin Oncol 3:1463 (1985).

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M-VAC

Methotrexate 30 mg/m2 IVB days 1,15 & 22
Vinblastine 3 mg/m2 IVB days 2,15 & 22
Doxorubicin 30 mg/m2 IVB day 2
Cisplatin 70 mg/m2 IV/1h day 2

Repeat cycle everry 28 days.

See cisplatin product information for pre- and post-hydration.

Ref: Sternberg CN, et al: J Urol 133:403 (1985).
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GC

gemcitabine 1,000 mg/m2 days 1, 8, and 15;
cisplatin 70 mg/m2 day 2

JCO:18, Issue 17 (September), 2000: 3068-3077
Phase III:Stage IV; GC provides a similar survival advantage to MVAC with a better safety profile and tolerability.

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CARBOPLATIN + TAXOL

Taxol 200 mg/m2 IV over 3 hours followed by
Carboplatin AUC=5

REF:
JCO 18:2537, 2000
JCO 16:1844, 1998
No randomized trials available. May not work as well as MVAC.
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MVMJ

Methotrexate 50 mg/m2 IVB days 1,15
Vinblastine 3 mg/m2 IVB day 1
Mitoxantrone 10 mg/m2 IVB day 1
Carboplatin 200 mg/m2 IVPB day 1

Repeat cycle every 21 days.

Ref: Waxman J., et al.: B J Urol 63;68:71 (1989).

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Transurethral Surgery Plus Radiation Therapy with Concurrent Cisplatin and 5-Fluorouracil Followed by Selective Bladder Preservation or Cystectomy Depending on the Initial Response
RTOG 95-06


CISPLATIN 15 mg/m2 i.v.
5FU 400 mg/m2 i.v. in the mornings on d 1, 2, 3, 15, 16, & 17.
On d 1, 3, 15, and 17, XRT was given immediately following the chemotherapy using twice-a-day 3 Gy per fraction cores to the pelvis for a total radiation dose of 24 Gy. Response was evaluated by cystoscopy, cytology, and rebiopsy four weeks later.
Patients with a complete response received consolidation therapy with the same drugs & doses on d 1, 2, 3, 15, 16, & 17 combined with twice-daily radiation therapy to the bladder & bladder tumor volume of 2.5 Gy per fraction for a total consolidation dose of 20 Gy & a total induction + consolidation dose to the bladder & bladder tumor of 44 Gy.
Patients who did not achieve a CR were advised to undergo prompt cystectomy, as were those with a subsequent invasive recurrence.

REF: The Oncologist, Vol. 5, No. 6, 471-476, December 2000
The median follow up was 29 months.
Of the 34 eligible patients, 26 had a visibly complete transurethral resection. One patient did not complete induction treatment due to acute hematologic toxicity. After induction treatment, 22 (67%) of the 33 patients had no tumor detectable on urine cytology or rebiopsy. Of the 11 patients who still had detectable tumor, six underwent radical cystectomy and five underwent consolidation chemoradiation (one because of refusal to have the recommended cystectomy and four because the treating institutions erroneously assigned them to receive consolidation chemoradiation rather than cystectomy). No patient has required a cystectomy for radiation toxicity. Six patients have died of bladder cancer. The actuarial overall survival at three years is 83%. The probability of surviving with an intact bladder is 66% at three years. A total of seven patients (21%) developed grade 3 or grade 4 hematologic toxicity in conjunction with this treatment.
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Phase I

CISPLATIN + GEMCITABINE + IFOSFAMIDE

Gemcitabine 800 mg/m2, &
Ifosfamide 1 g/m2
Given on day 1 & then repeated on day 8 & day 15 unless there was dose-limiting hematologic toxicity. 28-day course.
REF= JCO 20(13):2965, 2002
N=51; 10 participated in a pilot study, after which 41 patients were registered onto the phase II protocol. 48 pts (94.1%) had dose-limiting hematologic toxicity on day 8 or day 15. Nonhematologic toxicity of grade 3 or greater: nausea & vomiting (N=7, 13.7%) & infection (N=7, 13.7%). Responses could be assessed in 49 of 51 eligible patients; 2 CR (4.1%) & 18 PR (36.7%) ORR 40.8% (exact 95% confidence interval, 27% to 56%).
CONCLUSION: This regimen of cisplatin, gemcitabine, & ifosfamide is NOT feasible for WEEKLY administration because of hematologic toxicity. There was promising activity with only 2 doses per 28-day cycle. On the basis of these results, we have initiated a phase II trial of this combination given as a single dose every 14 days in patients with untreated, metastatic urothelial carcinoma.

Combined-Modality Treatment and Selective Organ Preservation in Invasive Bladder Cancer: Long-Term Results

To evaluate our long-term experience with combined modality treatment and selective bladder preservation and to identify factors that may predict treatment response, risk of relapse, and survival.

PATIENTS AND METHODS: Between 1982 and 2000, 415 patients with bladder cancer (high-risk T1, n = 89; T2 to T4, n = 326) were treated with radiotherapy (RT; n = 126) or radiochemotherapy (RCT; n = 289) after transurethral resection (TUR) of the tumor. Six weeks after RT/RCT, response was evaluated by restaging-TUR. In case of complete response (CR), patients were observed at regular intervals. In case of persistent or recurrent invasive tumor, salvage-cystectomy was recommended. Median follow-up was 60 months (range, 6 to 199 months).

RESULTS: CR was achieved in 72% of patients. Local control after CR without muscle-invasive relapse was maintained in 64% of patients at 10 years. Distant metastases were diagnosed in 98 patients with an actuarial rate of 35% at 10 years. Ten-year disease-specific survival was 42%, and more than 80% of survivors preserved their bladder. Early tumor stage and a complete TUR were the most important factors predicting CR and survival. RCT was more effective than RT alone in terms of CR and survival. Salvage cystectomy for local failure was associated with a 45% disease-specific survival rate at 10 years. Cystectomy because of a contracted bladder was restricted to 2% of patients.

CONCLUSION: TUR with RCT is a reasonable option for patients seeking an alternative to radical cystectomy. Ideal candidates are those with early-stage and unifocal tumors, in whom a complete TUR is accomplished.

STAGING SYSTEM

PRIMARY TUMOR (T)

The suffix "m" should be added to the appropriate T category to indicate multiple lesions. The suffix "is" may be added to any T to indicate the presence of associated carcinoma in situ.

TX: Primary tumor cannot be assessed
T0: No evidence of primary tumor
Ta: Noninvasive papillary carcinoma
Tis: Carcinoma in situ: "flat tumor"
T1: Tumor invades subepithelial connective tissue
T2: Tumor invades muscle
T2a: Tumor invades superficial muscle (inner half)
T2b: Tumor invades deep muscle (outer half)
T3: Tumor invades perivesical tissue
T3a: microscopically
T3b: macroscopically (extravesical mass)
T4: Tumor invades any of the following: prostate, uterus, vagina, pelvic wall, or abdominal wall.
T4a: Tumor invades the prostate, uterus, vagina
T4b: Tumor invades the pelvic wall, abdominal wall

REGIONAL LYMPH NODES (N)

Regional lymph nodes are those within the true pelvis; all others are distant lymph nodes.

NX: Regional lymph nodes cannot be assessed
N0: No regional lymph node metastasis
N1: Metastasis in a single lymph node, 2 cm or less in greatest dimension
N2: Metastasis in a single lymph node, more than 2 cm but not more than 5 cm in greatest dimension; or multiple lymph nodes, none more than 5 cm in greatest dimension
N3: Metastasis in a lymph node more than 5 cm in greatest dimension

Distant metastasis (M)
MX: Distant metastasis cannot be assessed
M0: No distant metastasis
M1: Distant metastasis

AJCC stage groupings

STAGE 0a
Ta, N0, M0

STAGE 0is
Tis, N0, M0

STAGE I
T1, N0, M0

STAGE II
T2a, N0, M0
T2b, N0, M0

STAGE III
T3a, N0, M0
T3b, N0, M0
T4a, N0, M0

STAGE IV
T4b, N0, M0
Any T, N1, M0
Any T, N2, M0
Any T, N3, M0
Any T, Any N, M1