Table 1.
Studies characteristics.
| Study | Study design | No ofpatients | Median FUP | Setting | Treatment | |
|---|---|---|---|---|---|---|
| Radiotherapy total dose (dose per fraction) | Chemotherapy | |||||
| Arnold 2004 (16) |
Phase II | 40 | 18 | Locally advanced SCCHN | 3.2 Gy/4 fx (0.8 Gy, days: 1, 2, 22, 23) | Paclitaxel 225 mg/m2 i.v. (days 1, 22) + Carboplatin 10 mg/ml (within 30 min after Paclitaxel) |
| Regine 2007 (17) |
Phase I/II | 10 | NR | Unresectable (5) or M1 pancreatic (liver) (4) or unresectable small bowel ca (1) | 2 dose levels: 0.6 and 0.7 Gy/fx, BID, days: 1, 2, 8, 9. Four cycles planned |
Gem 1,250 mg/m2 days: 1 and 8 at 10 mg/m2/min of a 3-week cycle |
| Valentini 2010 (26) |
Retrospect. | 22 | 6.5 | Relapsed or metastatic ca of lung (12), H&N (7), breast (2); esophagus (1) | 0.4 Gy BID repeated over 2 (lung, breast, and esophagus) or 4 (H&N) consecutive days, depending on the CHT schedule. Median total dose 8 Gy (range, 3.2–12.8 Gy). | Gem (1) or Cisplatin+Gem (1) or Pemetrexed (8) or Carboplatin (2) or Cisplatin+Fluorouracil (7) or Capecitabine (1) or Fluorouracil (1) or Docetaxel (1) |
| Mantini 2012 (21) |
Phase II | 19 | 6.5 | Advanced NSCLC | 1.6 Gy (0.4 Gy BID, days 1,2) | Concurrent Permetrexed 500 mg/m2 IV (cycles repeated fourfold every 21 days) |
| Nardone 2012 (24) |
Phase I | 10 | NR | Breast cancer stage IIA/B-IIIA | 0.4 Gy BID for 2 days every 21 days for 8–6 cycles | 2 CHT schedules: 1) 4 cycles of nonpegylated liposomal doxorubicin sequentially followed by 4 cycles of docetaxel; 2) 6 cycles of nonpegylated liposomal doxorubicin + concurrent docetaxel |
| Nardone 2014 (25) |
Phase II | 21 | 31 | Breast cancer stage IIA-IIIA |
0.4 Gy BID, days: 1, 2, 6 of every cycle. First RT fraction delivered before CHT, the second fraction given at least 5–6 h later; cycle repeated every 21 days; total dose: 9.6 Gy (6 cycles) | 6 cycles of liposomal anthracycline (50 mg/mq) and docetaxel (75 mg/mq) on day 1 of a 21-day cycle; cycle repeated every 21 days |
| Konski 2014 (20) |
Phase I | 27 | 8.4 | Locally advanced or metastatic pancreatic cancer | 3 RT dose level: 1) 28.8 Gy (0.4 Gy BID); 2) 28 Gy (0.5 Gy BID); 3) 28.8 Gy (0.6 Gy BID) days 1,2,8,9 | Gem IV days 1, 8 + Erlotinib once PO (21 day cycles) |
| Balducci 2014 (18) |
Prospective | 32 | 22.5 | Recurrent/ progressive GBM |
Two schedules: 1) 0.3 Gy BID, days: 1, 2, 8, 9, 15, 16, every 42 days (2 cycles: total dose of 7.2 Gy); 2) 0.4 Gy BID over 5 consecutive days, every 28 days (2 cycles: total dose of 8 Gy) | Two schedules: 1) Cisplatin (30 mg/m2 on days 1, 8, 15) + Fotemustine (40 mg/m2 on days 2,9,16) if recurrent or progressive disease during adjuvant TMZ, on days 1, 2, 8, 9, 15, and 16, every 42 days; 2) TMZ rechallenge (150/200 mg/m2) if recurrent or progressive disease more than 4 months after adjuvant TMZ, over 5 consecutive days, every 28 days |
| Beauchesne 2015 (19) |
Phase II | 40 | 48 | Newly diagnosed inoperable GBM | 67.5 Gy/90 fx (0.75 Gy each 3 daily doses, at least a 4-h interfraction interval; 5 days a week) | Concurrent TMZ (dose of 75 mg/m2 for 7 days a week). At the end of a 4-week break, CHT was resumed for up to 6 cycles of adjuvant TMZ treatment, every 28 days according to the standard 5-day regimen. |
| Das 2015 (27) |
Phase II | 24 | 30 | Locally advanced SCC of the cervix (stage IIB–IIIB) | 3.2 Gy/4fx (0.8 Gy BID) | Paclitaxel (175 mg/m2) + Carboplatin (AUC X 5) 3 weekly for 2 cycles followed by radical chemoradiation |
| Morganti 2016 (23) |
Phase II | 18 | 30 | Metastatic colorectal cancer | 2.4 Gy (0.2 Gy BID, days: 1, 2 of every cycle) | 12 FOLFIRI-B cycles (bevacizumab, irinotecan, bolus fluorouracil, and leucovorin with a 46-h infusion of fluorouracil, every 2 weeks) |
| Mattoli 2017 (22) |
Retrospect. | 44 | NR | NSCLC (stage IIIA-IIIB) | 100% patients: induction CHT + 0.4 Gy BID (days: 1,2 and 8,9 every cycle); 45% surgery; 59% neo-adjuvant CHT-RT (50.4Gy) | 100% patients: 2 cycles of concurrent Platinum; 59% neo-adjuvant CHT+RT |
FUP, follow-up; RT, radiotherapy; CHT, chemotherapy; SCCHN, squamous cell carcinoma of the head and neck; SCC, squamous cell carcinoma; RR, response rate; CR, complete response; PR, partial response; PFS, progression free survival; BID, bis in die; NRC, neoadjuvant radiochemotherapy; NAC, conventional neoadjuvant chemotherapy; PO, per oral; PMRR, pathological major response rate; TRG, tumor regression grade; GBM: glioblastoma multiforme, TMZ, temozolomide; Gem, gemcitabine.