Table 3.
Author (Year) |
Pt. No | Origin | 1 Stage at Treatment Initiation | Primary Systemic Therapy | Treatment | iBOR | 2 PFS | irAEs | 3 OS | Status |
---|---|---|---|---|---|---|---|---|---|---|
Wohlmuth (2020) [26] |
1 | Vulva | III C, unresectable | None | Pembrolizumab | iCPD | 2 | None | 18 | Alive with disease |
2 | Vulva | IV (lung) | None | Ipilimumab + nivolumab | iSD | 18 | Uveitis G1,peripheral sensory neuropathy G3 | 18 | Alive with disesase | |
3 | Vulva | IV (liver) | None | Ipilimumab + nivolumab | iCPD | 1 | None | 1 | Died of disease | |
4 | Vulva | IV (liver) | None | Nivolumab | iPR | 15 | Hepatitis G1 | 15 | Alive with disease | |
5 | Vagina | Distant (brain) | Nivolumab, adjuvant | Pembrolizumab | iSD | 4 | None | 16 | Died of disease | |
6 | Vulva | IV (lung) | None | Ipilimumab | iCR | 56 | None | 56 | Alive with NED | |
7 | Vulva | IV (lung, liver) | Interferon, adjuvant | 1. Ipilimumab 2. Pembrolizumab |
iCPD iSD |
3 4 |
Maculopapular exanthema G1, Hepatitis G1 None |
17 | Died of disease | |
8 | Vulva | IV (liver) | None | 1. Ipilimumab 2. Pembrolizumab |
iCPD iPR |
3 9 |
Maculopapular exanthema G1 None |
50 | Alive with disease | |
9 | Vulva | IV (lung, brain) | Carboplatin/paclitaxel | Ipilimumab | iCPD | 3 | None | 6 | Died of disease | |
10 | Vulva | IV (lung) | Dacarbazine | 1. Ipilimumab 2. Pembrolizumab |
iCPD iCR |
3 77 |
None Hyperthyroidism G2, DM G3,Erythema nodosum G1 |
87 | Alive with NED | |
11 | Vulva | IV (lung, bone) | None | Ipilimumab | iCPD | 1 | None | 1 | Died of disease | |
12 | Vulva | IV (lung, abdomen) | Carboplatin/paclitaxel | 1. Ipilimumab 2. Pembrolizumab |
iCPD iCPD |
3 3 |
None None |
16 | Died of disease | |
13 | Vulva | IV (lung, abdomen, soft tissue) | Carboplatin/paclitaxel | Ipilimumab | iSD | 2 | None | 13 | Died of disease | |
Indini (2019) [29] |
1 | Vulva | IV (lung) | CVD | Ipilimumab | iCPD | 4 | None | 7 | Died of disease |
2 | Vulva | IV (lung, bone) | None | Pembrolizumab | iPR | 10 | Arthralgia G2, hypothyroidism G2 | 10 | Alive with disease | |
3 | Vagina | Distant (liver) | None | Pembrolizumab | iCPD | 2 | None | 4 | Alive with disease | |
4 | Vagina | Distant (n.s.) | None | Nivolumab | iSD | 4 | Cutaneous rash G1 | 4 | Alive with disease | |
5 | Vagina | Distant (liver, pancreas, soft tissues, bone) | None | Ipilimumab | iCPD | 3 | None | 7 | Died of disease | |
6 | Vagina | Distant (lung) | Dacarbazine | Ipilimumab | iCPD | 3 | None | 18 | Died of disease | |
7 | Cervix | Distant (lung, liver) | None | Ipilimumab | iCPD | 2 | None | 2 | Died of disease | |
4 Quéreux (2017) [30] | 1 | Vulva or Vagina | 5: Distant (mucosa and/or lymph nodes) 1: Distant (liver) |
2: None 3: Chemotherapy 1: Nivolumab |
Ipilimumab | 4: iCPD | 1: Asthenia G1 1: Colitis G1 1: Rheumatoid arthritis G1 1: Colitis G3 |
n.s. | The survival rate at 1 year: 33% | |
2 | ||||||||||
3 | ||||||||||
4 | ||||||||||
5 | 1: iSD | 11 | 11 | |||||||
6 | 1: iPR | 31 | 31 | |||||||
7 | Vulva or Vagina |
6: Distant (mucosa and/or lymph nodes) 2: None |
4: None 1: Dacarbazine 1: BRAF and MEK inhibitors 2: Ipilimumab |
Nivolumab | 4: iPR 4: iCPD |
n.s. | 3: Asthenia G1 2: Maculopapular rush G1 2: Rheumatoid arthritis G2 1: Colitis G2 |
n.s | The survival rate at 1 year: 86% | |
8 | ||||||||||
9 | ||||||||||
10 | ||||||||||
11 | ||||||||||
12 | ||||||||||
13 | ||||||||||
14 | ||||||||||
15 | Vagina | Distant (mucosa, lymph nodes, lung) | None | Ipilimumab + Nivolumab | iPR | 5 | Asthenia G1, Hypothyroidism G2 |
12 | Alive with disease | |
4 Del Prete (2016) [31] | 1 | Vulva or Vagina |
7: n.s. (surgery for total excision) 1: n.s. (unresectable) |
1: pegylated interferon |
n.s. | n.s. | n.s. | |||
2 | 3: Ipilimumab | 1: iPR, 2: iPD |
n.s. | |||||||
3 | 1: Pembrolizumab | iSD | Alive with disease | |||||||
4 | 1: Interferon pegintron | iSD | Alive with NED | |||||||
5 | 3: Imatinib | 2: iPR, 1: iSD |
n.s. | |||||||
6 | 1: Nilotinib | iCPD | n.s. | |||||||
7 | 5: Chemotherapy | 1: iSD, 4: iCPD |
n.s. | |||||||
8 | ||||||||||
Schiavone (2016) [32] | 1 | Vagina | localized, Ballantyne I | None | Ipilimumab | iSD | 38 | Maculopapular rush G3, Diarrhea G1 | 38 | Alive with NED |
2 | Vagina | localized, Ballantyne I | None | Ipilimumab | iCPD | 2 | None | 16 | Died of disease | |
3 | Vagina | localized, Ballantyne I | None | Ipilimumab | iCR | 20 | None | 20 | Alive with NED | |
4 | Cervix | localized, Ballantyne I | None |
|
iCPD iSD |
9 n.s. |
Diarrhea G3 n.s. |
19 n.s. |
Alive with disease | |
Anko (2020) [33] |
1 | Vagina | Distant (liver, lung, bone) | None | Nivolumab | iPR/iCR | 17 | Thyroiditis, n.s | 17 | Alive |
2 | Cervix | II C (None) | None | (recurrence)Nivolumab | iCR | 33 | None | 33 | Alive with disease | |
Cocorocchio (2020) [34] |
1 | Vulva |
|
None |
|
iSD iCPD iPR |
10 4 11 |
Hyperglycemia G4 Hemiparesis, n.s. Vasculitis G2, uveitis G2 |
40 | Died of disease |
Komatsu-Fujii (2019) [35] | 1 | Vagina | Distant (lung) | None |
|
iCPD iCPD iCPD |
n.s n.s. n.s. |
n.s. n.s. n.s. |
n.s. | Alive with disease |
Yamashita (2019) [36] |
1 | Vulva | 1,2. IV (liver, lymph nodes) 3,4. IV (liver, lymph nodes, lung, gall bladder, renal duct) |
None |
|
iCPD iCPD iCPD iPR |
n.s. n.s. n.s. |
Maculopapular rush G2 | n.s. | Alive with disease |
Norwood (2019) [37] | 1 | Vagina | Regional | None | (recurrence) Ipilimumab + Nivolumab |
iSD | n.s. | Maculopapular rush G3, Colitis G2, Hyponatremia G2, Headache G2 |
n.s. | Alive with disease |
Kim (2018) [38] | 1 | Cervix | Distant (bone, spine, lung, lymph nodes) | None | (adjuvant therapy) Pembrolizumab |
iCPD | 0 | Maculopapular rush, n.s. | 9 | Died of disease |
Daix (2018) [39] | 1 | Vagina | Regional, unresectable | None | Nivolumab | iCR | 8 | Pruritus G1 | 8 | Alive with NED |
Nai (2018) [40] | 1 | Cervix | Distant (liver, kidney) | None | Ipilimumab + Nivolumab | iCPD | 0 | None | 12 | Died of disease |
Inoue (2018) [41] | 1 | Vagina | Distant (brain) | None | Nivolumab | iCPD | 2 | Hepatitis G3 | n.s. | Alive with disease |
1 Stage: AJCC staging classification for vulvar melanoma, and local/regional/distantfor vaginal or cervical melanomas; 2 PFS: from treatment initiation to date of progression or death; 3 OS: from treatment initiation to date of last follow-up or death; 4 No details of patients order in the treatment (ipilimumab, nivolumab, etc.). The leftmost number before colon indicates the number of patients in each group.Abbreviations: CVD indicates cisplatin-vinblastin-dacarbazine; Cervix, melanoma of uterine cervix; DM, diabetes mellitis; G, grade; iCPD, comfirmed progressive disease; irAEs, immune-related adverse events; NED, no evidence of disease; n.s., not specified; RT: radiotherapy.