Table 1 Synthesis of the data reported in selected clinical trials. Terms in bold within the 'Intervention' column indicate the specific medical intervention/treatment assessed in the trial. Terms in bold within the 'Outcomes' column indicate the trial's endpoints
From: Targeted drugs and Psycho-oncological intervention for breast cancer patients
Study | Intervention | Patients group | Number of patients | Length of the study | Outcomes |
|---|---|---|---|---|---|
Miller et al. 2007 [9] | Randomized, phase 3 trial. | Metastatic breast cancer | N = 722 (Control N = 354; Invervention N = 368) | 2.5 years | PFS> 5.9 months (p < 0.001) |
Efficacy and safety on paclitaxel with or without bevacizumab | OS >1.5 months (p < 0.16) | ||||
Spiegel et al. 2007 [33] | Randomized prospective trial on supportive-expressive group therapy | Metastatic breast cancer | N = 125 (Control N = 61; Intervention N = 64) | >1 year (14 years follow-up) | OS <2.6 months (p = 0.73) |
Kissane et al. 2007 [13] | Randomized controlled trial on supportive-expressive group therapy | Metastatic breast cancer (stage IV) | N = 227 (Control N = 80; Intervention N = 147) | >1 year (2 years follow-up) | OS >5.7 months (p = 0.60) |
EORTC QoL C-30 | |||||
Social functioning scale F = 4.56 (p = 0.03), Impact of Event Scale F = 4.61 (p = 0.04) | |||||
Mini-MAC | |||||
helpless/hopelessness F = 4.89 (p = 0.03) | |||||
Von Minckwitz et al. 2012 [11] | Randomized clinical trial on neoadjuvant therapy with or without bevacizumab | Non-metastatic HER2-negative breast cancer | N = 1948 (Control N = 969; Intervention N = 956) | 2.5 years | pCR >4 % (p = 0.04) |
Bear et al. 2012 [10] | Randomized clinical trial on neoadjuvant therapy with or without bevacizumab | Non-metastatic HER2-negative breast cancer | N = 1206 (Control N = 596; Intervention N = 595) | 2.5 years | pCR >6.3 % (p = 0.02) |
Andersen et al. 2008 [14] | Randomized clinical trial on psychological intervention | Non-metastatic breast cancer (stage IIA, IIIA or IIIB) | N = 227 (Control N = 113; Intervention N = 114) | 1 year (11 years follow-up) | OS >1.3 years (p = 0.016) |
Kissane et al. 2004 [15] | Randomized controlled trial on cognitive-existential group therapy | Non-metastatic breast cancer (stage I or II) | N = 303 (Control N = 149; Intervention N = 154) | 2 years (5 years follow-up) | OS <3.5 months (p = 0.31) |