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Table 1 Summary of traditional neoadjuvant studies

From: Neoadjuvant treatment of melanoma: case reports and review

 

Patients (n)

Study design, end point

Agent

Clinical response

Survival

Sasson et al. [5]

16, metastatic

Retrospective, OS

Various*

62.5% (7PR, 3CR)

OS – 68.8% DFS – 62.5%, median f/u 35 mo

Jouary et al. [6]

13, metastatic

Retrospective, OS

DTIC

60% did not progress.

OS - 31.6 vs 25.3 mo (study group vs. retrospective cohort)

Shah et al. [7]

19, Stage III

Phase II, ORR

Tem

16% (1PR, 2CR)

NR

Buzaid et al. [8]

64, Stage III

Phase II, ORR

Cis, Vin, IL2, DTIC, IFN

50%**(28PR, 4 CR)

Median OS 27 mo. Median DFS 13 mo

Gibbs et al. [9]

48, Stage III

Phase II, ORR

Cis, Vin, IL2, DTIC, IFN

38.9%# (13PR, 1CR)

79% OS, 65% PFS at 2.6 yrs.

Koyanagi et al. [10]

63, Stage III

Phase II, DFS

Cis, Vin, DTIC, IL2, IFN

NR

DFS- 70%, median f/u 30.4 mo. 2 yr OS – 80.9%

Lewis et al. [11]

92, Stage III

Phase II, OS

Cis, Vin, DTIC, IL2, IFN

26%##

RFS – 64% OS- 78%, median f/u 40.4 mo

Kounalakis et al. [12]

153, Stage III

Retrospective, OS

Cis, Vin, DTIC, IL2, IFN

55% + (14 PR, 14 CR)

5 yr OS-82% (micromet disease), and 77% (bulky disease)

Moschos et al. [13]

20, Stage III

Phase II, ORR

HDI

55% (8PR, 3 CR)

90% PFS at 1.5 yrs.

  1. *Study designed to compare utility of resection vs. no resection and had various chemotherapeutic regiments including: single agent DTIC or combination with camustine, cis-platin, tamoxifen, or interferon.
  2. **Reported histological response rate.
  3. #Only 36 of the 48 patients had clinically evaluable disease to assess response rates.
  4. ##Only 50 of the 92 patients had clinically evaluable disease to assess response rates.
  5. +Only 51 of the 153 patients had clinically evaluable disease to assess response rates.