Table 2.
Authors (year) | Histology | Phase | Patients enrolled | Treatment arm | Median age (years) | Median PFS (months) | Median OS (months) | Number for analysis | Severe infections | Reported infectious events |
---|---|---|---|---|---|---|---|---|---|---|
Natale et al (2009)47 | NSCLC | III | 168 | Vandetanib 300 mg | 61 | 2.6 | 6.1 | 83 | 3 | Pneumonia, sepsis |
Gefitinib | 63 | 1.9 | 7.4 | 85 | 0 | |||||
Herbst et al (2010)46 | NSCLC | III | 1,391 | Vandetanib 100 mg qd po + Doc | 59 | 4 | 10.3 | 689 | 46 | Febrile neutropenia |
Placebo + Doc | 59 | 3.2 | 9.9 | 690 | 38 | |||||
Barrios et al (2010)55 | ABC | III | 482 | Sunitinib 37.5 mg qd po | 53 | 2.8 | 15.3 | 238 | 1 | Septic shock |
Capecitabine | 53 | 4.2 | 24.6 | 240 | 0 | |||||
Scagliotti et al (2010)45 | NSCLC | III | 926 | Sorafenib 400 mg bid po + PTX + CBP | 62 | 4.6 | 10.7 | 436 | 38 | Febrile neutropenia, pneumonia, infections |
Placebo + PTX + CBP | 63 | 54 | 10.6 | 459 | 12 | |||||
Abou-Alfa et al (2010)54 | HCC | II | 96 | Doxorubicin + sorafenib 400 mg bid po qd | 66 | 6 | 13.7 | 47 | 0 | Febrile neutropenia |
Doxorubicin + placebo | 65 | 2.7 | 6.5 | 49 | 4 | |||||
Natale et al (2011)44 | NSCLC | III | 1,240 | Vandetanib 300 mg qd po | 61 | 2.6 | 6.8 | 623 | 9 | Pneumonia |
Erlotinib | 61 | 2 | 7.7 | 614 | 5 | |||||
Leboulleux et al (2012)52 | Thyroid cancer | II | 145 | Vandetanib 300 mg qd po | 63 | 11.1 | NR | 72 | 1 | Pneumonia |
Placebo | 64 | 5.9 | NR | 73 | 1 | |||||
Lee et al (2012)43 | NSCLC | III | 924 | Vandetanib 300 mg qd po | 60 | 1.9 | 8.5 | 619 | 47 | Infections, pneumonia |
Placebo | 60 | 1.8 | 7.8 | 303 | 21 | |||||
Wells et al (2012)51 | Thyroid cancer | III | 331 | Vandetanib 300 mg qd po | 50.7 | 30.5 | NR | 231 | 2 | Aspiration, pneumonia, staphylococcal sepsis |
Placebo | 53.4 | 19.3 | NR | 99 | 0 | |||||
Choueiri et al (2012)56 | Urothelial cancer | III | 142 | Vandetanib 100 mg qd po q3w + Doc | NR | 2.56 | 5.85 | 70 | 3 | Infections |
Placebo + Doc | NR | 1.58 | 7.03 | 72 | 4 | |||||
Goncalves et al (2012)57 | Pancreatic cancer | III | 104 | Sorafenib 400 mg bid pos + gemcitabine | 64 | 3.8 | 52 | 0 | Febrile neutropenia | |
Gemcitabine | 64 | 5.7 | 52 | 2 | ||||||
Scagliotti et al (2012)41 | NSCLC | III | 1,090 | Motesanib 125 mg qd po + PTX + CBP | 60 | 5.6 | 13 | 533 | 43 | Febrile neutropenia, pneumonia |
Placebo + PTX + CBP | 60 | 5.4 | 11 | 539 | 22 | |||||
Yi et al (2012)58 | Gastric cancer | II | 107 | Sunitinib 37.5 mg qd po + Doc | 54 | 3.9 | 8 | 56 | 15 | Febrile neutropenia |
Doc | 52 | 2.6 | 6.6 | 49 | 8 | |||||
Hoff et al (2012)49 | CRC | III | 860 | Cediranib 20 mg qd po + chemotherapy | 58 | 8.6 | 19.7 | 500 | 5 | Pneumonia, septic shock |
Placebo + chemotherapy | 59 | 8.3 | 18.9 | 358 | 3 | |||||
Scagliotti et al (2012)42 | NSCLC | III | 960 | Sunitinib 37.5 mg qd po + erlotinib | 61 | 3.6 | 9 | 473 | 1 | Respiratory tract infection |
Erlotinib | 61 | 2 | 8.5 | 477 | 0 | |||||
Carrato et al (2013)48 | CRC | III | 768 | Sunitinib 37.5 mg qd po + FOLFIRI | 59 | 7.8 | 20.3 | 384 | 32 | Neutropenic sepsis, febrile neutropenia, pneumonia, sepsis/septic shock |
Placebo + FOLFIRI | 58 | 8.4 | 19.8 | 384 | 14 | |||||
Grothey et al (2013)14 | CRC | III | 1,052 | Regorafenib 160 mg qd po | 61 | 6.4 | 505 | 6 | Fever, pneumonia | |
Placebo | 61 | 5 | 253 | 2 | ||||||
Demetri et al (2013)15 | GIST | III | 199 | Regorafenib 160 mg qd po | 60 | 4.8 | NR | 132 | 3 | Fever |
Placebo | 61 | 0.9 | NR | 66 | 0 | |||||
Serve et al (2013)61 | AML | III | 162 | Sorafenib 400 mg bid po + chemotherapy | NR | 7 | 15 | 80 | 15 | Pneumonia, sepsis |
Placebo + chemotherapy | NR | 5 | 13 | 82 | 4 | |||||
Flaherty et al (2013)59 | Melanoma | III | 823 | Sorafenib 400 mg bid po + PTX + CBP | 66 | 4.9 | 11.3 | 393 | 24 | Febrile neutropenia |
Placebo + PTX + CBP | 61 | 4.2 | 11.1 | 397 | 16 | |||||
Brose et al (2014)50 | Thyroid cancer | III | 417 | Sorafenib 400 mg bid po | 63 | 10.8 | NR | 207 | 3 | Fever |
Placebo | 63 | 5.8 | NR | 209 | 0 | |||||
Garon et al (2014)40 | NSCLC | III | 1,253 | Ramucirumab 10 mg/kg + Doc | 62 | 4.5 | 10.5 | 627 | 100 | Febrile neutropenia |
Placebo + Doc | 61 | 3 | 9.1 | 618 | 62 | |||||
Kudo et al (2014)53 | HCC | III | 502 | Brivanib 800 mg qd + TACE | 57 | 12 | 26.4 | 246 | 2 | Bacterial peritonitis, |
Placebo + TACE | 59 | 10.9 | 26.1 | 253 | 0 | pulmonary infection | ||||
Laurie et al (2014)39 | NSCLC | III | 306 | Cediranib 20 mg qd po + PTX + CBP | 63 | 5.5 | 12.2 | 153 | 9 | Febrile neutropenia |
Placebo + PTX + CBP | 62 | 5.5 | 12.1 | 153 | 5 | |||||
Reck et al (2014)38 | NSCLC | III | 655 | Nintedanib 200 mg bid po + Doc | 60 | 3.4 | 10.9 | 655 | 66 | Febrile neutropenia |
Placebo + Doc | 60 | 2.7 | 7.9 | 659 | 45 | |||||
Hutson et al (2014)60 | RCC | III | 512 | Sorafenib 400 mg bid po | 61 | 3.9 | 16.6 | 252 | 7 | Pneumonia |
Temsirolimus | 60 | 4.3 | 12.3 | 249 | 5 | |||||
Michaelson et al (2014)62 | CRPC | III | 873 | Sunitinib 37.5 mg qd po + prednisone | 69 | 5.6 | 13.1 | 581 | 3 | Pneumonia, sepsis |
Placebo + prednisone | 68 | 4.1 | 11.8 | 285 | 1 |
Abbreviations: PFS, progression-free survival; OS, overall survival; NSCLC, non-small-cell lung cancer; qd, once daily; po, per oral; Doc, docetaxel; ABC, advanced breast cancer; bid, twice daily; PTX, paclitaxel; CBP, carboplatin; HCC, hepatocellular carcinoma; NR, not reported; q3w, every 3 weeks; CRC, colorectal cancer; FOLFIRI, folinic acid (leucovorin), fluorouracil, and irinotecan; GIST, gastrointestinal stromal tumor; AML, acute myeloid leukemia; TACE, transcatheter arterial chemoembolization; RCC, renal cell carcinoma; CRPC, castration-resistant prostate cancer.