Table 1.
Prospective Studies of Skin-Directed Therapies for Skin Metastases
| Study | Year | No. of Patients | No. of Lesions | Local Therapy | No. of Lesions With CR | Definition of CR | No. of Lesions With Objective Response | Definition of Objective Response |
|---|---|---|---|---|---|---|---|---|
| Heller et al44* | 1996 | 4 | 12 | ECT | 5 | “Absence of any trace of tumor” | 7 | CR + PR |
| Sersa et al11 | 2000 | 9 | 27 | ECT† | 3 | WHO, 1979 | 13 | CR + PR |
| Rodriguez-Cuevas et al45* | 2001 | 6 | 29 | ECT | 11 | “Complete response” | 27 | CR + PR |
| Byrne et al28 | 2005 | 16 | 53 | ECT | 34 | “No residual disease” | 39 | CR + PR |
| Gaudy et al29 | 2006 | 12 | 24 | ECT† | 11 | “Total disappearance of the lesion” | 14 | CR + PR |
| Marty et al23 | 2006 | 41 | 171 | ECT | 126 | WHO, 1997 | 145 | CR + PR |
| Quaglino et al46 | 2008 | 14 | 233 | ECT | 136 | WHO, 1997 | 216 | CR + PR |
| Matthiessen et al30 | 2011 | 24 | 94 | ECT | 58 | RECIST, 2000 | 76 | CR + PR |
| Benevento et al47 | 2012 | 12 | 142 | ECT | 107 | RECIST, 2000 | 131 | CR + PR‡ |
| Campana et al21 | 2012 | 35 | 35 | ECT | 19 | RECIST, 2000 | 32 | CR + PR |
| Kendler et al22* | 2013 | 3 | 79 | ECT | 7 | RECIST, 2009 | 7 | CR + PR‡ |
| Sperduto et al48 | 1991 | 20 | 20 | PDT | 4 | “Clinical and pathologic regression of all tumor in the treatment field” | 13 | CR + PR‡ |
| Cairnduff et al49 | 1994 | 5 | 14 | PDT | 5 | “Absence of clinically evident tumor” | 5 | CR + PR‡ |
| Baas et al50 | 1996 | 4 | 20 | PDT† | 15 | “Complete response” | 18 | CR + PR‡ |
| Kaplan et al51 | 1998 | 3 | 13 | PDT | 13 | “Complete reduction of tumor” | 13 | CR + PR‡ |
| Mang et al52 | 1998 | 8 | 86 | PDT | 79 | “Complete response” | 86 | CR + PR‡ |
| Overgaard et al36 | 1985 | NA | 15 | RT | 10 | “Complete disappearance of the tumor in the irradiated field” | 15 | CR + PR |
| Menéndez et al35 | 2009 | 7 | 88 | RT | 52 | “Complete response” | 61 | CR + PR |
| Cohen et al53 | 1978 | 18 | 766 | ILT | NA | NA | 647 | Clinical and pathologic “regression” |
| Nathanson et al54 | 1979 | 22 | 22 | ILT | 3 | “Complete disappearance” | 10 | CR + PR |
| Cascinelli et al37 | 1993 | 16 | 47 | ILT | NA | NA | 24 | ≥ 30% reduction in tumor volume |
| Stewart et al55* | 1999 | 23 | 23 | ILT | NA | NA | 7 | “Local regression” |
| Hoeller et al56 | 2001 | 7 | 7 | ILT | 2 | “100% decrease size change of injected lesion” | 5 | CR + PR‡ |
| Stopeck et al57 | 2001 | 29 | 29 | ILT | 1 | “Disappearance of all of the clinical evidence of tumor” | 5 | ≥ 25% reduction in product of perpendicular diameter |
| Radny et al58 | 2003 | 23 | 237 | ILT | 209 | “Disappearance of all clinical evidence of the … tumor” | 230 | CR + PR‡ |
| Oratz et al59 | 2003 | 25 | 244 | ILT | 114 | 100% tumor volume regression; response must last ≥ 28 days | 130 | CR + PR; Response must last ≥ 28 days |
| Byrne et al28 | 2005 | 16 | 19 | ILT | 5 | “No residual disease” | 6 | CR + PR |
| Triozzi et al60 | 2005 | NA | 14 | ILT | 0 | “Disappearance of all the clinical evidence of tumor” | 0 | CR + PR‡ |
| Gonzalez et al61 | 2006 | 77 | 77 | ILT | 2 | WHO§ | 7 | CR + PR |
| Kimata et al62 | 2006 | 6 | 5 | ILT | 0 | “Necrosis or disappearance of all tumor cells” | 4 | CR + PR‡ |
| Gaudy et al29 | 2006 | 12 | 16 | ILT† | 2 | “Total disappearance of the lesion” | 6 | CR + PR |
| Dummer et al63 | 2008 | 25 | 25 | ILT† | 3 | “Absence of detectable residual disease maintained for a minimum of 4 weeks” | 6 | CR + PR |
| Hofmann et al19 | 2008 | 5 | 5 | ILT | 1 | “Complete response” and “complete regression” | 2 | > 25% response to tumor volume; 1 CR + 1 SD‡ |
| Thompson et al20 | 2008 | 11 | 26 | ILT | 9 | RECIST, 2000 | 11 | CR + PR |
| Bedikian et al25 | 2010 | 85 | 255 | ILT | 4 | RECIST, 2000 | 15 | CR + PR |
| Weide et al26 | 2010 | 48 | 894 | ILT | 704 | Disappearance of lesion; no regrowth for 6 months | 710 | CR + PR‡ |
| Unger et al27 | 1992 | 24 | 24 | TT | 4 | “Complete remission” | 7 | CR + PR‡ |
| Unger et al31 | 1993 | 52 | 52 | TT† | 1 | WHO§ | 11 | CR + PR |
| Terwogt et al32 | 1999 | 30 | 30 | TT | 7 | Complete disappearance of all treated lesions for ≥ 4 weeks | 13 | CR + PR |
| Smorenburg et al33 | 2000 | 18 | 18 | TT† | 0 | WHO§ | 4 | CR + PR‡ |
| Leonard et al24 | 2001 | 24 | 19 | TT† | 2 | WHO, 1979 | 8 | CR + PR |
| Eilender et al34* | 2006 | 42 | 24 | TT† | 1 | Complete disappearance of all treated lesions for ≥ 4 weeks | 7 | CR + PR‡ |
| Salazar et al40 | 2011 | 10 | 10 | TT† | 3 | “Modified WHO criteria”§ | 7 | CR + PR‡ |
| Florin et al41 | 2012 | 5 | 45 | TT | 19 | “Complete response” | 44 | CR + PR |
| Adams et al42 | 2012 | 10 | 10 | TT† | 0 | “Absence of any detectable residual disease” | 2 | CR + PR |
| Plesnicar et al43 | 1982 | 19 | 19 | ILT + RT | 14 | “Cleared completely” | 15 | CR + PR |
| Lai et al12 | 2003 | 7 | 7 | TT + RT | 3 | Disappearance of all treated skin lesions ≥ 4 weeks | 6 | CR + PR |
| Green et al38 | 2007 | 10 | 178 | TT + ILT | 74 | “Impalpable” and “disappear” | 92 | CR + PR |
| Li et al39 | 2010 | 11 | 11 | TT + PDT | 8 | RECIST§ | 11 | CR + PR |
Abbreviations: CR, complete response; ECT, electrochemotherapy; ILT, intralesional therapy; NA, not available; PDT, photodynamic therapy; PR, partial response; RT, radiotherapy; SD, stable disease; TT, topical therapy.
*
Study divided by histology for subgroup analyses (see Appendix Table A1, online only, for information on histology details by study).
†
Concurrent systemic therapy used/allowed.
‡
Definition not explicitly listed. Authors' definition used.
§
Year of response criteria used not stated.