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Kidney

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Mechanism of Action
Dose Modifications (Renal)
Dose Modifications (hepatic)
MDR

OPTIONS:
High-dose IL2
Subcutaneous IL2 (outpatient regimen)
IL2+INF+5FU
Thalidomide
Vinblastine
Non-myeloablative approach

CONTINOUS INFUSION IL-2
Cancer J Sci Am 1997 Dec;3 Suppl 1:S85-91
Metastatic renal cell carcinoma: long-term survival after therapy with high-dose continuous-infusion interleukin-2.
Gold PJ, Thompson JA, Markowitz DR, Neumann S, Fefer A.
University of Washington School of Medicine, Seattle 98195-6043, USA.
PURPOSE: This article undertakes to define the response rate, long-term survival, and toxicity in patients with metastatic renal cell carcinoma (MRCC) treated with high-dose continuous intravenous infusion (CIV) recombinant interleukin-2 (rIL-2) with or without lymphokine-activated killer (LAK) cells. PATIENTS AND METHODS: One hundred twenty-three consecutive patients received CIV rIL-2 (18-22 MIU/m2/day on days 1-5, and 6-8 MIU/m2/day on days 10-19) on one of five sequential protocols at the University of Washington between 1988 and 1995. The first 76 patients received LAK cells. The median age was 55 years (range, 32-76 years), and 71% had undergone prior nephrectomy. RESULTS: Nine patients achieved a complete response (7.3%) and 14 patients achieved a partial response (11.4%) for an overall response rate of 19% (95% confidence interval, 12%-26%). The median survival was 19 months, and the 5-year survival was 20%. Seven of nine complete responders (78%) remain in continuing complete response at 43+ to 109+ months. Intensive care unit and vasopressor support were required in 42% and 23% of patients, respectively, who received rIL-2 + LAK cells, and in 18% and 4% of those who received rIL-2 alone. There was one treatment-related death. CONCLUSION: We report the largest single-institution experience and the longest survival for patients with MRCC treated with CIV rIL-2. The administration of rIL-2 by CIV is associated with less frequent intensive care unit and vasopressor support than with high-dose intravenous bolus regimens, and hence may enhance the therapeutic index in patients with MRCC

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HIGH-DOSE IL-2

IL-2 600,000 0r 720,000 IU/Kg administered by 15 minute IV infusion Q8 hours for as many as 14 consecutive doses during 5 days as clinically tolerated.

Follow by a second identical cycle after an approximate 10-day rest with courses repeated Q 6-12 weeks.

CR 7% PR 20% with median duration of response 54 months (3-107+)

REF:

Cancer J Sci Amer 3:S70, 1997.

J Clin Oncol; 13(3):688-96 1995

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IL-2 Subcutaneous (outpatient)

IL2 given QD, 5 days per week X 6 weeks.

During the first 5-day cycle: 18 x 10(6) IU given QD; in the following cycles, the doses in the first 2 days are reduced to 9 x 10(6) IU.

After a 3-week rest period, treatment is repeated in patients who had a response or stable disease (SD). Prophylaxis: Acetaminophen 250 to 500 mg given PO Q4-6 hours.

REF: J Clin Oncol; 10(7):1119-23 1992.

After 6 weeks, 26 patients were assessable for response. 2 patients (8%) had a CR, 4 (15%) had a PR, & 13 (50%) had SD. A second cycle of 6 weeks was given to 19 patients; 1 patient with a PR and 6 with SD showed progression. Duration of the CR was 17+ & 19+ months, & length of the PR was 2, 8, 11, and 11+ months. The median survival of the patients who were nonresponders & responders was 10 and 20+ months, respectively, & for all patients was 13 months. One patient died of MI & brain stem ischemia. Systemic side effects in the other patients were tolerated & accepted, & included transient inflammation & local induration at the injection sites, fever and chills, and nausea.



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IL2+INF+5FU Regimen (Atzpodien et al)



rIL-2 20 X 10(6) IU/m2 SC TIW weeks 1,4. 5X 10(6) IU/m2 SC TIW weeks 2,3,5,6



IFN-a 6 x 10(6) U/m2 SC Q week 1,4 & TIW weeks 2,3,5,6



5FU 750 mg/m2 IV bolus Q week 4,5,6,7,8



REF: Proc ASCO 1994:13:247 (Absr 773)

Important Note: This regimen remains contraversial. Some studies have shown RR as high as 47% and some have not been able to reproduce results. Expect high toxicity.



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Thalidomide

Start at 200 mg PO QD

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Non-myeloablative approach



NEJM 343(11): 750-758, 2000.



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Interferon vs Interferon + Thalidomide

ECOG study- active

IFN 1 MU BID



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Primary tumor (T)
TX: Primary tumor cannot be assessed
T0: No evidence of primary tumor
T1: Tumor 7 cm or less in greatest dimension limited to the kidney
T2: Tumor more than 7 cm in greatest dimension limited to the kidney
T3: Tumor extends into major veins or invades adrenal gland or perinephric tissues but not beyond Gerota's fascia
T3a: Tumor invades adrenal gland or perinephric tissues but not beyond Gerota's fascia
T3b: Tumor grossly extends into the renal vein(s) or vena cava below the diaphragm
T3c: Tumor grossly extends into the renal vein(s) or vena cava above the diaphragm
T4: Tumor invades beyond Gerota's fascia

Regional lymph nodes (N)
NX: Regional lymph nodes cannot be assessed
N0: No regional lymph node metastasis
N1: Metastasis in a single regional lymph node
N2: Metastasis in more than 1 regional lymph node
Note: Laterality does not affect the N classification.

Distant metastasis (M)

MX: Distant metastasis cannot be assessed
M0: No distant metastasis
M1: Distant metastasis

AJCC stage groupings

STAGE I
T1, N0, M0
STAGE II
T2, N0, M0
STAGE III
T1, N1, M0
T2, N1, M0
T3a, N0, M0
T3a, N1, M0
T3b, N0, M0
T3b, N1, M0
T3c, N0, M0
T3c, N1, M0
STAGE IV
T4, N0, M0
T4, N1, M0
Any T, N2, M0
Any T, Any N, M1